Apparatus for controlling an implantable medical device
A system and methods of maintaining communication with a medical device for exchange of information, instructions, and programs, in a highly reliable manner. Apparatus and methods for accomplishing this task include: 1) The inclusion of a locating device in the system, in close proximity to an implanted device, but which does not drain the implanted device battery. The locating device may be implanted or external to the body. 2) The use of motion detection and global positioning system devices to locate elements within a communicating system for the medical device; 3) The assessment of received signal quality by elements of the system; 4) The use of a notification system for a device user who is moving out of range of communications; and 5) Documenting the absolute and functional integrity of instructions received by the medical device.
This application is a divisional of U.S. patent application Ser. No. 12/657,155, filed Jan. 14, 2010, and issued today (Jan. 17, 2017) as U.S. Pat. No. 9,545,520.
The subject matter of this application is related to that of:
1) U.S. patent application Ser. No. 10/460,458, published on Dec. 18, 2003 as U.S. Patent Publication No. US/2003/0233129, now U.S. Pat. No. 7,277,752;
2) U.S. patent application Ser. No. 11/502,484, published on Feb. 2, 2007 as U.S. Patent Publication No. US/2007/0043585A1, now allowed;
3) U.S. patent application Ser. No. 11/893,897, published on Dec. 27, 2007 as U.S. Patent Publication No. US/2007/0299473, now U.S. Pat. No. 7,769,465;
4) U.S. patent application Ser. No. 11/895,934, published on Mar. 6, 2008 as U.S. Patent Publication No. US/2008/0058884, now U.S. Pat. No. 8,214,043;
5) U.S. patent application Ser. No. 12/154,079, published on Dec. 4, 2008 as U.S. Patent Publication No. US/2008/0300659, now U.S. Pat. No. 8,473,065;
6) U.S. patent application Ser. No. 12/455,940, published on Nov. 5, 2009 as U.S. Patent Publication No. US/2009/0276013, now U.S. Pat. No. 7,840,277;
7) Provisional Application No. 61/204,957, filed Jan. 13, 2009, priority of which is hereby claimed; and
8) U.S. patent application Ser. No. 12/657,155, filed Jan. 14, 2010 (now U.S. Pat. No. 9,545,520).
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- The aforementioned U.S. Patent and published Patent Applications are incorporated herein by reference.
Implantable medical devices (“IMDs”) exhibit growth in terms of:
a) the development of new devices which perform functions not previously performed;
b) the development of more sophisticated devices that replace previous simpler models; and
c) the number of implanted units per unit time.
Some devices perform “mission critical” functions—i.e. they stimulate heart, or brain, or deliver powerful drugs.
The devices are designed to function largely autonomously. That is, they interact with the patient in whom they are implanted (“the IMD owner”), and interact with an MD only on the infrequent occasions when the MD is present.
From time to time, the actions of these devices may result in unintended and/or harmful consequences due to:
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- a) improper or suboptimal programming of the device by a physician or technician;
- b) a change in the condition of a patient, such that what was appropriate programming in the past, is no longer appropriate given the patients altered medical condition;
- c) malfunction of the device itself;
- d) malfunction of a sensor which provides information to the device; and
- e) electromagnetic interference.
Under these circumstances, it is desirable to have a means of very rapidly addressing a malfunction or pseudo-malfunction [e.g. suboptimal programming], e.g. by reprogramming the device so that in the short term, one or more undesirable actions are prevented. Though the patient may go to a physician's office or seek help in an Emergency Room, these actions may require hours to days to execute. On the other hand, the ability to remotely communicate with an implantable device, and to control its function remotely, can provide a solution that is available in minutes or seconds, and can provide real-time corrections as well.
The present application addresses various aspects of the communications between an IMD and a remotely located medical professional. Whereas the preferred embodiment of the invention is an IMD, the inventive concepts described herein may be applied to other devices—medical and non-medical—as well.
Abbreviations and DefinitionsAdjacent—two communication units which may communicate directly
Alpha Unit—a communications unit which is upstream from a beta unit
Beta Unit—a communications unit which is downstream from an alpha unit
CCSI—composite communication status information
CPD—cell phone device
CS—central station
Downstream—refers to a communications unit which is linked to the IMD by fewer hops than a corresponding upstream unit. The upstream unit relays a signal originating in the CS to the downstream unit.
EID—external RFID device
GPS—global positioning system
ICD—implantable cardioverter-defibrillator
IID—implantable RFID device
IMD—implantable medical device
IMD owner—the person in whom an IMD is implanted
MD/A/P—motion detecting accelerormeter/piezoelectric crystal
MDC—motion detecting capability
PM—Pacemaker
Quiescent—a state in which mobile communicating units are not moving
RFID—radiofrequency identification device
SU—stationary unit
“Transmitting” may mean (a) as an RF signal, (b) over the telephone system, (c) via modem to the internet or (d) over a private carrier
Upstream—refers to a communications unit which is linked to the central station by fewer hops than a corresponding downstream unit. The upstream unit relays a signal originating in the CS to the downstream unit.
WD—wrist device
SUMMARY OF THE INVENTIONAmong the complexities of remotely controlling an IMD are the need for extremely reliable communications with the IMD, the need to not excessively drain the battery of the IMD, and the need for communications security. To accomplish these goals, one must create an environment in which the IMD owner is, at all times (or as close to ‘all times’ as possible) near one or more communications repeater units. Ideally, at least one of the units would be either (a) very near the IMD owner, (b) carried by the IMD owner (e.g. a cell phone device, as discussed hereinbelow), (c) touching the IMD owner's body (e.g. a wrist device, as discussed hereinbelow), (d) worn by the IMD owner or even implanted in the IMD owner. Redundancy among these communication units increases the reliability of the system. By designating one or more of the units as a locator unit, i.e. a unit which is very likely to be in the same location as the IMD owner at virtually all times, the communication system may be optimized on a frequent basis without draining the IMD battery; i.e. optimization then involves elements of the system communicating with the locator unit, rather than with the IMD. By creating a system in which one repeater unit is very near the IMD owner, then at such times that communication with the IMD is necessary, IMD power output can be low, and thus IMD battery drain can be similarly low.
In the event that the system finds itself incapable of establishing a robust communications link between the IMD owner and a central station, then a means of notifying one or more individuals who can rectify the situation is desirable. The notified individual could be the IMD owner, a person living or working with or near the IMD owner, or a system administrator who handles the task of seeking out the IMD owner. Notification may be via one or more of the devices in the IMD owner's environment which also serve as a repeater unit, e.g. the WD or the CPD. Among the short term remedies for the IMD owner are (a) movement to a more optimal location, (b) recharge or replace the battery of a repeater unit whose battery has depleted, or (c) no action. The longer term options may entail an alteration in the environment, e.g. placing a more powerful stationary unit in a location frequented by the IMD owner which repeatedly poses a communications challenge (e.g. his basement).
IMD communication networks are possible which are:
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- (a) self organizing—i.e. each repeater unit optimizes communications with two or more neighbors;
- (b) globally organized—i.e. a single unit optimizes the entire system of communicating units; or
- (c) locally organized—i.e. two or more units each optimize communications among a local group (e.g. the CPD optimizes communications in the environment of the IMD and another upstream organizing unit optimizes communications at a point between the CPD and the CS.
Devices that have been referred to as “cell phones” now are increasingly sophisticated, with substantial and increasing bandwidth access, memory, computational and advanced communication features. Such devices, suitably modified from a commercial off-the-shelf version, or a version which is initially designed for an IMD owner, could function as a repeater unit, a notification unit and a local or global communication system manager. Although such a unit could also be designated as the unit closest to the IMD-owner, a wearable or implantable device might do better.
Besides communications management, sophisticated information management techniques are required for a remote management of an IMD. The invention described herein addresses the need for verification that instruction(s)/program(s) sent to the IMD are properly received/installed, and that the IMD functions properly after receipt of the instruction(s)/program(s). Robust encryption/decryption techniques to prevent unauthorized access to the IMD, are also described herein. In conjunction with outside access to the IMD, optional IMD owner consent methods are also described.
Features of the Invention1) A multi-repeater communications system/network which allows for (a) maximization of signal quality on a dynamic basis, (b) maximization of user freedom and (c) minimization of IMD battery drain.
2) Implantable communications repeater units are a possibility.
3) Wearable Repeater Units (e.g. WD) are a possibility.
4) RFIDs as locating device and/or repeater device are a possibility, including (but not limited to) the battery-less type of RFID; including but not limited to implantable RFIDs and RFIDs embedded in clothing and personal items (wallet, “pocket book,” “handbag” etc.).
5) Cell phone as communications repeater unit is a possibility.
6) Repeater Units with loss/misplacement detection, based on patterns of motion, GSR analysis and temperature analysis
7) IMD owner notification in the event of an actual or a potential communications fault. One or more of the repeater units may also include a notification function, (or notification may be via a stand-alone notification device).
8) Interactive IMD owner notification system
9) Use of motion detection apparatus in PMs and ICDs for communications management
10) Use of MD/A/P in repeater units for communications management
11) Multimodal motion detection including (a) signal quality, (b) GPS and (c) MD/A/P and use of the position/motion/acceleration information, signal quality information and handshake information to optimize communications
12) Handshake format which manages communications, for use with the system
13) Architectures are possible with repeater units (a) in series, (b) in parallel, (c) in a network with both series and parallel elements
14) Dynamic communication system architecture: As needed, a communications unit can be bypassed, a communications route can be altered, a channel can be switched, a communications mode can be altered. Both series and parallel communication elements may be incorporated into the communications network.
15) Communication systems are possible with:
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- a) local communications management: i.e. each communications unit co-manages itself and its neighbors;
- b) global communications management: i.e. one communications unit manages all others; and
- c) regional communications management: i.e. two or more communications units each manage a group of local communicating units.
16) Use of battery capacity for communications management decisions
17) System for verification of proper transmission of an instruction/program from CS to IMD
18) Systems for verification of proper functioning of an IMD with a new instruction/program
19) Static systems for highly secure encryption/decryption key generation and maintenance for the management of IMDs which are remotely accessible
20) Dynamic systems for highly secure encryption/decryption key generation and maintenance for the management of IMDs which are remotely accessible
21) IMD owner notification in the event an instruction/program needs to be installed, and an IMD owner permission granting algorithm
The four relay units are shown by way of example, and numerous other examples are possible including those with a) more relay units, b) fewer relay units, c) with more of one kind of unit, d) fewer or none of another kind, and e) in which the sequence of relay units differs. Stationary units are in a fixed location and may have a hard-wired connection to a public telephone system or a connection (hard-wired or not) to an internet-based telephone system.
Cell phone devices are not hard wired and may be a commercial off-the-shelf unit with capability to simultaneously communicate with two other units. Alternatively, it may be a modified cellular phone unit, optimized for function in the capacity discussed hereinabove and hereinbelow. The cell phone's special value is that the likelihood that it is near to a person at any one time is greater than would be the case for a stationary unit (e.g. a SU located in the patient's home).
The wrist device (which may be located on other patient body parts other than the wrist—e.g. ankle, chest, etc.), also is of value because of the high likelihood of patient proximity. Because it may be even closer to the patient than a cell phone, the energy expenditure for communicating with it from a downstream device (i.e. a device which is the IMD, or and RFID) may be even less than that required for communication between the downstream device and the cell phone.
A variety of RFIDs are possible including a) external RFIDs, and b) internal RFIDs. The RFID may be a passive unit, a semi-passive one, an active one or a beacon type. These are intended to be in very close proximity to the IMD, and therefore to result in very minimal drain on the IMD battery if communication is required between the IMD and the RFID. Furthermore, RFIDs allow the system to locate an IMD by assessing the location of the IMD-companion (i.e. the RFID, or a wrist device). This approach also avoids draining the IMD battery during locating efforts.
The communication route from CS to IMD need not be the same as that from IMD to CS. Furthermore, the route of either or both legs may vary during the course of one communication session.
Any particular device may provide a locator function, a relay function or both. For example, in one embodiment of the invention, an RFID may perform a locator function in conjunction with an SU, while the same SU communicates with the IMD via the CPD.
The table below shows examples of systems with 1, 2 and 3 repeater units. In the example in the table, the RFID may function as a repeater unit.
Examples of IMD-CS Communication System Elements with One to Three Repeaters
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- Care would be taken to prevent damage to the RFID at the time of defibrillator discharge;
- Care would be taken to prevent the IMD from effectively decreasing the conductive surface area of the can of the ICD to the extent that the transcardiac voltage and current gradients would be meaningfully altered; and
- It might be possible for the IMD to passively obtain some energy for self supply at the time of an ICD discharge.
Proper communication between CS and IMD is monitored and enhanced by a number of features discussed in conjunction with
In the terminology used herein, S1 signals are beacon or handshake signals sent from any unit to another further downstream, requesting a response from the downstream unit, while S2 signals are the response. The signals may involve adjacent units (e.g. the upstream and midstream unit), or non-adjacent units (the upstream and downstream units). There may be a 1:1 relationship between the number of S1s and the number of S2s (the format of U.S. Pat. No. 7,277,752), or a many to one relationship (discussed herein). Other types of communication informational signals (discussed hereinbelow) may be exchanged as part of the process of communications enhancement (e.g. downstream unit indicates to upstream unit that S1 intensity is declining). Other types of communication management protocols and numerous variations will be familiar to those skilled in the art.
a) the sum of the allowed S1-S2 delay and the “S2-S1 delay”; or
b) the sum of the actual S1-S2 interval and the S2-S1 delay.
Possible management options for non-response after Z and after Z+n S1s are shown in
Other algorithms are possible with which:
a) there are fewer or more options in each “tier” or group of options, where the first tier in the current algorithm is defined as the regime wherein the value of counter A ranges from Z up to Z+n−1, and the second tier in the current algorithm is defined as the regime wherein the value of counter A is greater than or equal to Z+n;
b) some of the options listed for the first tier (value of counter A being>the number Z), are instead listed for the second tier (value of counter A being>or equal to the number Z+n);
c) option A7 is instead listed for the first tier;
d) Z is the number “1”, in which case one S2 is expected for each S1;
e) Z is a non-fixed number, whose value may depend on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.);
f) n is a non-fixed number, whose value may depend on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.); and/or
g) there are fewer or more tiers.
If an S2 is not received within the ordinarily expected interval (designated J1 in the figure), options B0 to B6 are possible choices. If an S2 is still not received by time J2 then options B7, B8 and B9 are possible choices. If an S2 is still not received after an additional interval of K, then any of options B0 to B7, and B9 are possible, and each may be repeated every K seconds thereafter until an S2 is received.
Other algorithms are possible with:
a) fewer or more options in each “tier”, where the definition of tier is analogous to that of
b) some of the options listed for the first tier are instead listed for the second tier;
c) one or more of options B7 and B9 are instead listed for the first tier;
d) The value of J1 is equal to the value of the S1-S1 interval, so that one S2 is expected for each S1;
e) J1 is a non-fixed value, which changes from circumstance to circumstance, whose value depends on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.);
f) J2 is a non-fixed value, which changes from circumstance to circumstance, whose value depends on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.);
g) K is a non-fixed value, which changes from circumstance to circumstance, whose value depends on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.); and/or
h) fewer or more tiers.
In this format, a handshake interruption is indicated at the downstream unit by non-receipt of an S1 after a certain amount of time since the last received S1. S1s are continuously emitted by the upstream unit. When an S1 is received downstream; the downstream communications unit returns an S2, and also starts a timer which allows for determination of whether the next S1 is received within an interval L which equals the S1-S1 interval. (The S1-S1 interval may be an industry standard or may be signaled to the downstream unit previously by the upstream unit.) If the next S1 is received within the time L, the timer of this downstream unit is reset; if not, options C0 to C8 are possibilities.
Other algorithms are possible with:
a) fewer or more options in the event of a non-received S2;
b) L is a non-fixed value, which changes from circumstance to circumstance, whose value depends on one or more other parameters (e.g. GPS related information, the importance of a transmission as indicated by the sender, recent communication history details etc.); and/or
c) more tiers.
Careful management of the energy which remains in the battery or batteries of a portable device, and especially careful management of the energy which remains in the battery or batteries of an implanted device are important to maximize the duration of use of these devices (before recharge, battery replacement, or device replacement is necessary). Such management is one of the subjects of the patent and applications incorporated herein by reference.
a) decrease power consumption, if possible,
b) notifying the IMD owner and/or the CS of a declining level of power reserve, and
c) if necessary, bypassing a communications unit with a failing battery.
The algorithm calls for the monitoring of “battery voltage” but other parameters of battery reserve could be used including:
a) the impedance of one or a combination of the individual batteries, if there is more than one;
b) the duration of time since the battery was either charged, replaced or installed; and
c) a summation of current drain (as a function of time) multiplied by the time of such current drain, i.e. to generate an estimate of the number of amp-hours that a battery has been used while taking into account that current drain is not constant.
Furthermore, voltage details could be examined including:
a) the voltage of one or a combination of the individual batteries, if there is more than one;
b) the voltage at times that the unit is quiescent, or relative so; and
c) the voltage at times of relatively high power drain (e.g. during high voltage capacitor charging of an ICD, or at times that transmitter power is maximal).
Embodiments of the invention are possible with:
a) fewer or more tiers than the number shown in the figure;
b) no monitoring of battery reserves;
c) a substantially continuous relationship between battery reserve and power consumption, rather than a stepwise one; and
d) sharing the information about battery reserves with either (i) the adjacent communication units [defined hereinbelow in conjunction with
Other techniques for battery conservation and management will be apparent to those skilled in the art.
a) the relative positions of two communicating units;
b) relative movement of two communicating units;
c) the strength of the received signal at each respective unit; and/or
d) the rate of change in signal strength.
may be used to optimize communications between the two units.
Variations include:
a) a greater or lesser number of zones;
b) a substantially continuous relationship between the distance between communicating units and a parameter (e.g. output power) which is adjusted based on distance;
c) zones which may all be the same width, zone widths which bear an algebraic relationship to distance (e.g. width of zone decreases as the square or cube of the distance); or zone widths which have a non-algebraic relationship to distance, or no relationship to distance;
d) zone shapes which may not be radially symmetric, and some or all zones which are shaped differently than other (or all other) zones; and
e) zone shapes and/or sizes which are constant in time vs. zone shapes and/or sizes which vary with time (e.g. variation as battery reserve falls or variation as the device/device antenna orientation varies, as weather varies, as sunspot conditions vary and/or as obstacles vary).
In one or more embodiments of the invention, a zone-based and/or distance [between communicating units]-based format:
a) may not be used at all (e.g. a format based on signal strength or change in signal strength may be used);
b) may be used intermittently; or
c) may be used as one of a number of parameters which are inputted in the optimization of communications.
a) is used along with the parameter itself;
b) is used instead of the primary parameter; or
c) is not used at all.
Algorithms are also possible in which a higher order derivative of either parameter is used, e.g. acceleration (i.e. the second derivative of position with respect to time) alone, or in addition to the other parameters mentioned herein.
Signal quality has been divided into “good”, “fair” and “poor”. In addition a slowly deteriorating signal has been classified as fair, and a rapidly deteriorating one has been classified as poor. Similarly, distance has been classified as good, fair and poor; and a slowly increasing distance has been classified as fair, while a rapidly increasing distance as poor. Algorithms are possible in which the information concerning rates of change of position and signal strength are used in different ways than in the algorithm in the example; many such approaches will be obvious to those skilled in the art.
The pentagon symbol in
Algorithms are possible with:
a) a greater number of tiers of classification and therapy;
b) a lesser number of tiers of classification and therapy;
c) the same “curative” options differently distributed among the tiers;
d) a smaller or larger number of curative options; and/or
e) different curative options.
Referring to both
In the event of either:
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- a) deteriorating communication conditions (the deterioration likely to concern the less robust links, i.e. one or more of the links in the vicinity of the IMD), or
- b) an inability to communicate between IMD and one of the repeater units in its vicinity,
then a means of notifying the IMD owner [i.e. the person in whom the IMD is implanted] is desirable.
Notification is discussed generally first, and an exemplary algorithm is discussed hereinbelow in conjunction with
The notification itself may be delivered:
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- a) by a phone call to the IMD owner's CPD;
- b) by a verbal announcement coming from a WD or CPD (e.g. a previously stored voice prompt);
- c) by a tone, chime, vibration, screen message, flashing light source, etc. from a WD or CPD; or
- d) by a tone, chime, buzzing, computer screen message, television screen message, flashing light source, etc. from a stationary source in the IMD owner's home, workplace, motor vehicle, or any other place likely to be frequented by the IMD owner; or
- e) by any device or means which will attract the attention of the IMD owner.
Alternatively (or if none of the above means is successful in obtaining the attention of the IMD owner), notification of a spouse, other family member (who preferably but not necessarily live with or near the IMD owner), neighbor or colleague in the workplace may be attempted.
a) a handshake failure between communication units detected at an upstream unit, e.g.:
i) option A6 [
ii) option A8 [
iii) option A7 [
iv) option B6 [
v) option B8 [
vi) option B7 [
b) a handshake failure between communication units detected at a downstream unit, e.g. option C7 [
c) a fall in battery voltage at the communications unit which includes the notification mechanism, e.g. options D3 [
d) a fall in signal quality at the notification device, e.g. options E1 [
e) a fall in signal quality at the communications unit which is upstream from the notification device, e.g. options F1 [
f) a determination by the communications unit which includes the notification device that the distance between it and the upstream communications unit (as determined by GPS) is suboptimal, e.g.:
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- option E1 [
FIG. 11 ], due to distance slowly increasing or in a somewhat marginal - range;
- option E7 [
FIG. 11 ], option E8 [FIG. 11 ] (exercised via the CS) due to distance - rapidly increasing or in a very marginal range; and
g) a determination by the communications unit which includes the notification device that the distance between it and the downstream communications unit (as determined by GPS) is suboptimal, e.g.: - option F1 [
FIG. 12 ], due to distance slowly increasing or in a somewhat marginal - range;
- option F7 [
FIG. 12 ], option F8 [FIG. 12 ] (exercised via the CS) due to distance - rapidly increasing or in a very marginal range;
- option E1 [
If a medical professional in the CS or elsewhere wishes to remotely access the IMD, and the arrangement with the IMD owner is that the IMD owner's permission is required for such access (see hereinbelow), then the notification device may inform the IMD owner of a permission request. The medical professional may indicate the level of urgency, which may influence the quality of the notification (see hereinbelow).
Other contingencies in which the notification of the IMD owner may be desirable include:
a) a fall in battery voltage at a communications unit either upstream or downstream from the unit which includes the notification mechanism [and reported to the unit which includes the notification mechanism];
b) the receipt of a signal by the communications unit which includes the notification device that the distance is suboptimal between two communicating communication units, neither of which is that of the notification device; and
c) the receipt of a signal indicating that the IMD owner's wrist device is no longer in contact with the IMD owner's wrist, as assessed by (i) a change in impedance between two contact electrodes, or (ii) a change in temperature sensed by the device.
The notification algorithm illustrated by
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- a) there is no response by the IMD owner to a low level notification; or
- b) there is no correction of the low level fault by the IMD owner within a certain time interval.
The notification algorithm calls for an upgrade of the level of notification from intermediate to high in the event that either:
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- a) there is no response by the IMD owner to an intermediate level notification; or
- b) there is no correction of the intermediate level fault by the IMD owner within a certain time interval.
IMD owner notification for a consent is indicated as either low or intermediate urgency, because in a state of high urgency, it is possible or likely that IMD owner consent might be bypassed. Nevertheless, consent formats (see hereinbelow) are possible in which the IMD owner must agree to any and all outside access to his unit; With this format, a consent request of high urgency would be possible. An option such as G5 (louder longer tone) could be employed right from the start in such a circumstance.
Embodiments of the device are possible with:
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- a) a greater number of levels of urgency (and with an equal number of corresponding qualities of notification);
- b) a lesser number of levels of urgency;
- c) an algorithm in which the quality or type of notification at one level of urgency may be the
- same as that of another level (e.g. the intermediate level results in production of the same
- tone as that of the low level), and
- d) different sensory effects than the sounds stated in the figure.
The algorithm may be modified to allow either the IMD owner or the CS to:
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- a) turn off an alarm (e.g. in a situation in which it repeats frequently);
- b) modify the criteria for triggering the alarm;
- c) modify the quality of the alarm; or
- d) modify the amount of time before an alarm occurs (four such intervals shown in the figure).
Many other notification algorithms are possible, and will be obvious to those skilled in the art.
The case of communication between the CS and an SU is a trivial one, since neither is likely to move. (By definition, an SU does not move, and only limited examples of a mobile CS [e.g. certain peripheral CSs, as defined in U.S. patent application Ser. No. 11/502,484] are possible.) The units that are expected to move from time to time are the IMD itself, an internal RFID if part of the system, an external RFID if part of the system, a WD if part of the system, and a CPD, if part of the system.
Many pacemakers and ICDs have so called rate responsive capability, e.g. can operate in pacing modes such as VVIR, DDDR, etc. Such units detect motion by an onboard piezoelectric crystal, or by an accelerometer, and use the information to modulate pacing rate. However, if information about detected motion was shared with an upstream unit (e.g. an RFID, a WD, or a CPD), then the upstream unit could decrease handshake frequency or signal strength during times when the downstream unit is stationary, thereby conserving battery reserves. The IMD itself could use the motion information to minimize current drain for its own communication management (e.g. decrease power output if communications have been good, and if no detected IMD motion has occurred since the time of good communications.) Including such motion detecting apparatus in a CPD, a WD or an RFID would be possible.
In principle, a communications unit with motion detecting apparatus could be moving at a perfectly constant velocity away from another unit with which it is communicating; Because the velocity in this cited example is constant, neither a piezoelectric crystal nor an accelerometer would detect motion. This would constitute a case where motion detecting apparatus fails to detect such motion. However:
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- a) There would have to be some acceleration at the start of the motion; and
- b) Other systems in place (e.g. apparatus for examining signal strength, response to handshake signals, or GPS signals) could provide additional information which indicates that one communication unit is moving with respect to the other.
-
- a) the approach shown in
FIG. 16A could be used as the sole determinant of motion, - b) the approach shown in
FIG. 16B , in which non-motion (or minimal motion, or a derived parameter which reports minimal motion) is the sole reported item, or - c) an approach in which both motion and non-motion/minimal motion (or derived parameters of each) are separately assessed in parallel, as shown in
FIGS. 16A and 16B .
- a) the approach shown in
Furthermore, families of algorithms such as that shown in
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- a) those in which only positive activity signals are sent;
- b) those in which only negative activity signals are sent;
- c) those in which both positive and negative activity signals are sent;
- d) those with no delays;
- e) those in which there is a single delay, which occurs at a point other than after “MOTION PARAMETER<M2” (e.g. between “SEND+ACTIVITY SIGNAL” and “MOTION PARAMETER<M2”);
- f) those with multiple delays (e.g. before “MOTION PARAMETER<M1” and before “MOTION PARAMETER<M2”); and
- g) combinations of a)-f).
d) Architecture in which All Movable Units have MDC; and
e) Architecture for a General System Nomenclature and DefinitionsThe term “downstream” refers to the communication direction from the CS to the IMD; the term upstream” refers to the communication direction from the IMD to the CS.
As indicated in the figure, if a particular unit is designated as “relay unit U”, then the next unit immediate upstream (i.e. without any intervening unit) is designated as “relay unit U+1”. For example, if unit U is a WD, unit U+1 may be a CPD. The next upstream unit from relay unit U+1 is designated “relay unit U+2”, and the next upstream unit from relay unit U+2 is designated “relay unit U+3”.
The next unit immediate downstream from unit U (i.e. without any intervening unit) is designated as “relay unit U−1”. For example, if unit U is a WD, unit U−1 may be a RFID, or the IMD itself. The next downstream unit from relay unit U−1 is “relay unit U−2”, and the next unit downstream from relay unit U−2 is designated “relay unit U−3”.
The term “adjacent” refers to two units which, using the nomenclature and architecture shown in
Motion detecting capability, “MDC” refers to a unit having the ability to detect its own motion. Such ability could:
-
- A) result from either of the types of motion detecting apparatus that pacemakers and ICDs use, i.e. accelerometers or piezoelectric crystal detectors, which hereinbelow are referred to as “MD/A/P”;
- B) result from a GPS-based system; or
- C) be derived from signal strength information (i.e. If there is a signal source of constant intensity at one location, and signal detection apparatus at another location, then the detection of a signal with gradually declining intensity over a period of time, suggests that the detection apparatus and the source are moving away from each other).
The “activity frontier” refers to the boundary between (i) one or more adjacent moving units and (ii) a non-moving unit. An “upstream activity frontier” is the boundary between (i) the most upstream moving unit of a group of adjacent moving units and (ii) the next upstream neighbor, which is non-moving. A “downstream activity frontier” is the boundary between (i) the most downstream moving unit of a group of adjacent moving units and (ii) the next downstream neighbor, which is non-moving. Thus, if the IMD owner is moving and is wearing a WD (and hence the WD is moving), and the IMD owner has a CPD which is nearby but is stationary, the upstream activity frontier is defined as the WD. If the IMD owner is at home with his CPD and neither are moving, but the IMD owner left the WD in a moving vehicle, then the WD is both the upstream and the downstream activity frontier.
If none of the mobile elements are moving, the situation is referred to as a “quiescent state”. If there is incomplete information about whether all elements are stationary, then an adverb may be added to define the likelihood of a quiescent state, based on the number of non-moving elements, e.g. a “possibly quiescent state” if two mobile elements are quiescent, and a probably quiescent state if three mobile elements are quiescent.
General Principles:(1) Use of Activity Information: Using motion information can help to optimize communications between adjacent units and decrease battery drain. If communication between adjacent units was of good quality at time t, then
-
- a) it is likely to be of good quality at time t+x, if during the interval between t and t+x the distance between adjacent units did not increase, which is likely to be the case if neither of the two adjacent units moved during the time interval; and
- b) it is less likely to be of good quality at time t+x, if during the interval between t and t+x the distance between adjacent units increased, a condition whose likelihood is increased if at least one of the two units moved.
(2) Techniques and Rationale for Locally Increasing Communication Efforts: In order to compensate for the motion of either of a pair of communicating units, any one or more of a number of actions may be taken to “increase the assiduousness of communication” between the units of this pair, including: - a) increase the power output of the upstream member of the pair on the channel for downstream communications with its neighbor;
- b) increase the power output of the downstream member of the pair on the channel for upstream communications with its neighbor;
- c) increase the sensitivity of the upstream member to signals from downstream;
- d) increase the sensitivity of the downstream member to signals from upstream;
- e) increase the frequency of handshake signals between the two communicating elements, e.g., increase the repetition rate of S1s for the upstream element and/or increase the ratio of number of S2s to number of S1s for the downstream element; and/or
- f) if necessary, i.e. if during the period of motion signal quality is decreasing, change the communications channel or mode or route for communications between the upstream and the downstream elements.
Other communication optimization approaches will be obvious to those skilled in the art.
(3) Two Adjacent Units with Different Activity Profiles: The Activity Frontier: If one member of a pair of adjacent units is moving and the other is not, then the link between these two is a preferred locus for an increase in the assiduousness of communications, by using one or more of the approaches listed in (2) hereinabove. The rationale for the increase in assiduousness is that it is possible that the detected movement may result in an increasing degree of separation between the moving and the adjacent non-moving unit. For example, if the IMD owner is wearing a WD which has motion detecting capability, (MDC), and the IMD owner is moving, but the CPD is not moving, then the WD/CPD junction is a more vulnerable communications link, than it would be if neither device was in motion. The WD would be considered the upstream activity frontier, and efforts to locally increase the assiduousness of communications would include:
-
- a) increasing the power output of the CPD on the channel for communications with the WD;
- b) increasing the power output of the WD on the channel for communications with the CPD;
- c) increasing the sensitivity of the CPD to signals from the WD;
- d) increasing the sensitivity of the WD to signals from CPD;
- e) increasing the frequency of S1s from the CPD and/or increasing the ratio of number of S2s to number of S1s at the WD; and/or
- f) if necessary, i.e. if during the period of motion signal quality is decreasing, changing the communications channel or mode or route for communications between the CPD and the WD.
It would also be possible to forgo doing all of a)-f) in the event of detected motion.
If the IMD owner is moving, then the upstream activity frontier defines the most upstream point of repeater units that are carried by or moving with the IMD owner. Since the downstream activity frontier is defined as the most downstream moving unit among a number of adjacent moving units, in the case of a moving IMD owner, the downstream activity frontier is the IMD. Since the IMD has no downstream neighbor, in cases where the IMD owner is moving, no adjustments need be made at the downstream activity frontier. However, if a repeater unit (e.g. the CPD) is accidentally left on a moving vehicle, and if the next downstream unit (i.e. the WD) is not moving, then a downstream activity frontier exists (in this case at the CPD), and an increase in communications assiduousness at the downstream activity frontier (i.e. for communications between the CPD and the WD) is called for.
(4) Two Adjacent Units, Both of which are Moving: If both members of a pair of adjacent units are moving, then there is a substantial possibility that the two units are moving together (e.g. the IMD owner is wearing a wrist device, and begins to walk). Additional information that would support the two moving together includes:
-
- A) The moment that movement begins for one member of the pair is substantially the same as the moment that movement begins for the other member of the pair;
- B) If movement temporarily halts for one unit, it halts or is substantially reduced for the other, in a similar time frame; and it resumes for both in a substantially similar time frame;
- C) If a third communications unit, adjacent to one of the two units in the aforementioned pair has MDC, that third unit's MDC also detects motion in a similar time frame to that for the aforementioned pair of units;
- D) If the two members of the pair both have GPS capability, then movement of the two units substantially together could be confirmed by comparing GPS information from each; and
- E) If a signal of a given power is transmitted from one unit of an adjacent pair and is received with signal strength which remains constant over a period of time at the other unit of the pair.
(5) No Increase in Communication Efforts at Junction of Two Moving Units: If two adjacent units are both moving, then assuming [as per (4) above] that they are moving together leads to the conclusion that the measures to increase the assiduousness of communication between them [as listed in 2) above] should not be undertaken.
(6) Two Adjacent, Both of which are Not Moving: The Quiescent State: If both members of a pair of adjacent units are not moving, then there is a substantial possibility that: - A) additional mobile units, if any, are not moving; and
- B) the IMD owner is not moving.
Additional information that would support a “quiescent state,” i.e. a state in which all mobile units are not moving is as follows:
-
- A) If there is a third communications unit, adjacent to one of the two units in the aforementioned pair, and that third unit has MDC, and that third unit's MDC also does not detect motion, then such non-detection of motion increases the likelihood of a quiescent state.
- B) If either of the two members of the pair (or both) have GPS capability, then GPS information may be used to further define the likelihood of a quiescent state. For example:
- i) If a stationary state is reported from a GPS in one member of the pair of units, and a stationary state is reported from the other member of the pair of units by MD/A/P, a possibly quiescent state may be concluded.
- ii) If a stationary state is reported from GPS in each member of adjacent units, then even if neither of these units have MD/A/P, the conclusion of a possibly quiescent state is warranted;
- iii) Clearly, the certainty of determination of a quiescent state increases with increasing numbers of detectors reporting no motion. Thus if there are reports of no motion from each of three detectors among a pair of units (e.g. from a MD/A/P in one unit and a GPS in each of the two units, or from a GPS in one unit and MD/A/P in each of the two units), then the likelihood of a quiescent state is greater than if there were two such reports. If both units have MD/A/P and both units have GPS, and all four reports indicate no motion, there is even greater certainty about the conclusion of the existence of a quiescent state.
Note is made of the facts that the primary data from GPS is a determination of the position of a unit, and that the primary data from MD/A/P is the detection of an acceleration. Therefore:
-
- a) Velocity information would have to be derived information for a GPS-based determination—the calculation of which will be obvious to those skilled in the art; and
- b) In principle, one may have a state of substantially constant velocity which would not cause the an accelerometer or piezoelectric motion detecting apparatus to report a state of activity. (In fact, perfectly constant linear motion should cause no activity signal from either an accelerometer or piezoelectric device, and small deviations from perfectly linear motion may fall below the threshold for activity detection.)
In short, each of MD/A/P and GPS look at motion differently, and their respective analyses may complement each other.
C) If a signal of a given power is transmitted from one unit of an adjacent pair and is received with signal strength which remains constant over a period of time at the other unit of the pair, this supports non-motion. Although a conclusion of non-motion based on signal strength could, under certain circumstances be inaccurate (e.g. if one unit is executing angular motion with respect to the other), the monitoring of signal strength has the advantage of leading to the suggestion of some clearly remedial actions such as increasing either the power output at the source or the sensitivity at the receiving end. Other remedial actions will be obvious to those skilled in the art.
Each of three modalities, (i) signal quality information, (ii) GPS information, and (iii) MD/A/P information may be used alone or in combination to assess whether a state of motion does or does not exist. Furthermore, one or more motion detecting modalities situated on two or more communicating units may be used to determine whether the motion is local (e.g. the case of a lost/misplaced unit [see hereinbelow]), or global (e.g. IMD and WD and CPD moving together).
(7) Techniques and Rationale for Locally Decreasing Communication Efforts: If a determination is made that two or more communicating units are not moving (or are moving in a manner such that their relative positions are fixed), then it may be advantageous to take measures to decrease the assiduousness of local communication efforts in anticipation of a stable spatial relationship between each pair of non-moving units. The decrease may save battery power, and decrease sensitivity to outside interference. Examples of specific actions to accomplish this task include:
-
- a) decreasing the power output of the upstream member of the pair on the channel for downstream communications with its neighbor;
- b) decreasing the power output of the downstream member of the pair on the channel for upstream communications with its neighbor;
- c) decreasing the sensitivity of the upstream member to signals from downstream;
- d) decreasing the sensitivity of the downstream member to signals from upstream; and/or
- e) decreasing the frequency of handshake signals between the two communicating elements, e.g., decreasing the repetition rate of S1 s for the upstream element and/or decreasing the ratio of number of S2s to number of S1s for the downstream element.
Other such approaches will be obvious to those skilled in the art.
(8) Techniques for Communications Management when Not All Units have MD/A/P: Approaches include:
-
- a) looking further upstream, downstream, or in both directions:
- i) If the activity status of unit U is unknown, then for upstream communications, the activity status of unit U+1 gives suggestive (though not unequivocal) information about the motion status of unit U; Further corroborating information may be sought by examining the state of motion of (I) unit U+2, (II) unit U−1, or (III) both units U+2 and U−1. Thus if the activity status of unit U is unknown but the activity status of both of units U−1 and U+1 are identical, then it is even more likely that the activity status of unit U is the same as that of unit U+1 (and of unit U−1), than would be the case if only the activity status of U+1 was available. Similarly, if the activity status of unit U is unknown, then for downstream communications, the activity status of unit U−1 gives suggestive (though not unequivocal) information about the motion status of unit U; Further corroborating information may be sought by examining the state of motion of (I) unit U−2, (II) unit U+1, or (III) both units U−2 and U+1.
- ii) If the activity status of an upstream units is unknown, then looking downstream may provide useful information about the upstream state of motion. For example, if the activity status of unit U is unknown, and the activity status of unit U+1 is unknown, then for upstream communications, the activity status of unit U−1 may be useful. Similarly, if the activity status of unit U is unknown, and the activity status of unit U−1 is unknown, then for downstream communications, the activity status of unit U+1 may be useful.
- iii) If necessary looking even further upstream or downstream may be useful. For example, if the activity status of unit U is unknown, and the activity status of unit U+1 is unknown, then for upstream communications, the activity status of unit U+2 may give suggestive (though not unequivocal) information about the motion status of unit U;
similarly, if necessary, looking two or more units downstream may prove useful for downstream communications; - b) looking at GPS data and attempting to make a motion determination based on that information;
- c) looking at signal strength and attempting to make a motion determination based on that information; and/or
- d) combinations of a)-c)
(9) Lost or Misplaced Unit: If a communications unit has a motion state which is the opposite of both of its neighbors, it may be lost or misplaced. There are two possible families of motion states that define this condition: - a) If the activity sensor of a communications unit shows motion while the activity sensors of each of the neighboring communication units do not, then the unit associated with the sensor indicating movement may be lost or misplaced. For example: If the WD activity sensor shows that the WD is moving, while (i) the IMD sensor shows no motion, and (ii) the CPD sensor shows no motion, then the WD may have been left off of the IMD owner in a location where it is subject to movement (e.g. in someone else's automobile).
- b) If the activity sensor of a communications unit shows no motion while the activity sensors of each of the neighboring communication units show motion, then the unit associated with the sensor indicating no motion may be lost or misplaced. For example, the IMD owner may have left the home, taking along his CPD but accidentally leaving behind his WD.
- a) looking further upstream, downstream, or in both directions:
Remedies for a lost/misplaced communications unit include:
-
- a) notify the IMD owner (e.g. by sending a message via the CPD);
- b) notify the CS; and/or
- c) the two communications units which are adjacent to the lost/misplaced unit (e.g. the IMD and the CPD, in the example hereinabove) communicate with each other until the lost/misplaced unit is returned to the vicinity of its neighbors [see (10) hereinbelow];
(10) Bypass of a Communications Unit Possible: Under certain circumstances, it may be advantageous to have one communications unit bypass its neighbor and communicate directly with a unit which is further upstream or downstream. Using the nomenclature defined hereinabove, this would entail a circumstance where, for example, unit U communicates directly with unit U+2 (or U−2) or directly with unit U+3 (or U−3). In the example, the bypass of unit U+1 (or U−1) could occur because U+1 (or U−1): - a) is lost or misplaced;
- b) has a failing or failed battery; or
- c) is geometrically situated such that a communication path which bypasses U+1 (or U−1) is more efficient.
An example of c) would be, as shown in
Methods of determining that it would be desirable to bypass a unit include:
-
- a) the pattern of motion described hereinabove in paragraph (9) [Lost or Misplaced Unit], i.e. a sequence of three adjacent communication units whose motion is either (i) positive, negative, positive, or (ii) negative, positive, negative;
- b) the detection of a low battery voltage in a unit;
- c) detection of geometric relationship between U, U+1 and U+2 which was given as an example immediately hereinabove by either (i) GPS, and/or (ii) signal strength. In the case of signal strength, the expected pattern would be:
- I) good signal strength for communications between units U and U+2; and
- II) less than good signal strength for at least one of:
- communications between units U and U+1, and
- communications between units U+1 and U+2.
-
- a) at unit U+2: there are poor quality S1s from unit U+1, but
- i) at unit U+2: there are good quality S1s from unit U, and
- ii) at unit U: there are good quality S2s from unit U+2;
- b) at unit U: there are poor quality S2s from unit U+1, but
- i) at unit U+2: there are good quality S1s from unit U, and
- ii) at unit U: there are good quality S2s from unit U+2;
- c) at unit U+1: there are poor quality S1s from unit U, but
- i) at unit U+2: there are good quality S1s from unit U, and
- ii) at unit U: there are good quality S2s from unit U+2; and/or
- d) at unit U+1: there are poor quality S2s from unit U+2, and
- i) at unit U+2: there are good quality S1s from unit U, and
- ii) at unit U: there are good quality S2s from unit U+2.
(11) Local vs. Central vs. Semi-Central Communication Control:FIG. 19A , and many of the algorithms illustrated hereinabove and hereinbelow illustrate local control, i.e. a particular communications unit uses information from itself and/or from an adjacent unit to adjust communications (e.g. poor quality of a received S1 at unit U results in an increase in the sensitivity of unit U to incoming S1s).
- a) at unit U+2: there are poor quality S1s from unit U+1, but
However, it would be possible to designate one communications unit as a central control unit (which may or may not be the central station), which receives one or more of (a) signal quality data, (b) GPS data, (c) motion data, and (d) battery information from one or more communication units (from all units in a preferred embodiment of the invention), and uses some or all of that information to determine a set of optimum values of communication parameters (e.g. route, power output of each unit, sensitivity of each unit, etc) for the entire system. These optimum values may change from time to time (e.g. depending on the locations of the communicating units). Furthermore, the choice of which unit is to be the central control unit may change from time to time (e.g. an upstairs SU may be the appropriate choice when the IMD owner is on an upper floor of a multi-floor home, while a downstairs SU may be more appropriate once the IMD owner descends to one of the lower floors). The selection of which unit is to be the central communications
-
- may be fixed (e.g. always the central station),
- may involve a preset sequence ([i] central station if certain conditions obtain, if not, [ii] home SU, if not, [iii] office [SU]), or
- may involve a process whereby the choice is made at any moment based on current system conditions (e.g. [i] the unit which at any moment has the best communications with each of the other units in the system, or [ii] the unit which is most centrally located among the units, or [iii] considerations based on battery reserve, or [iv] other considerations, or [v] combinations of [i] to [iv]).
It would also be possible to designate each of two or more communication units as a semi-central control unit. For example, unit U might be the semi-central control unit for each of units U−1, U and U+1; while unit U+3 might be the semi-central control unit for each of units U+2, U+3 and U+4.
(12) Activity Signal Need Not Be All-Or-None: Implantable pacemakers and ICDs with activity responsive modes (e.g. VVIR, DDDR) generally have a graded response to activity, i.e. within certain limits, more activity results in greater upward adjustment of the pacing rate. The response to activity may be linear or non-linear, over a certain range of heart rates. An activity threshold may be set which determines the sensitivity of the detection apparatus to motion. This is the state of the art, and multiple preferred embodiments of the invention may incorporate some or all of these features. In the specification hereinbelow activity detection is frequently referred to as an all-or-none phenomenon, but approaches in which evaluate intensity of activity are possible.
For example: Certain patterns of low level motion may be part of an in-home routine that require only a small step-up, if any, in the assiduousness of communication, while higher level patterns of motion may suggest that the IMD owner is leaving the home, or is performing an unknown activity. The system may be programmed to recognize this distinction in advance, or may have learning programs, which, over a period of time, may learn to recognize the distinction. For example, if a low level of activity during the early morning and late evening hours consistently is not associated with a significant decrease in unit-to-unit signal amplitude, the system may learn to recognize that these events are related to getting dressed and undressed, brushing teeth, etc.
Other examples will be obvious to those skilled in the art.
(13) During the Unit-to Unit Exchange of Activity Information, Inter-Unit Communications are Assumed to be Intact. In the event that they are not, multiple remedies are available, including those discussed hereinabove in conjunction with
(14) Actual CS-to-IMD Communications and IMD-to-CS Communications Use Communication Parameters Selected and Optimized During the Communication Optimization Routine. The vast majority of the life of an IMD is likely not to require communication with a CS or MD. The communication optimization protocols described herein allow for frequent system/route/parameter optimization, so that if/when the moment arrives when there is need for a communication, the likelihood is very high that a high quality exchange of information between CS and IMD can occur immediately. (See further discussion hereinbelow regarding storage of optimization information, especially in conjunction with
Ongoing optimization of the link between the IMD itself and the first repeater unit is a step that does consume some IMD battery energy. Ways to limit such consumption are:
-
- a) If there is a high level of certainty that the first repeater unit will be in very close proximity to the IMD, then only very infrequent confirmation of the operability of the IMD to first repeater unit may be performed;
- b) The type of asymmetric handshaking format between the first repeater unit and the IMD with a ratio of many first repeater S1s to few IMD S2s, would allow the IMD to not transmit unless it failed to receive timely S1s.
In
In a system with multiple communicating units, at least one of which has motion detection capability, one, some, or all of the units may have motion detecting capability. This section considers two specific simple architectures: (a) that in which only one mobile communications unit has MDC; and (b) that in which all mobile communication units have MDC. The general case—in which any unit may or may not have MDC—is discussed in the next section.
Referring to the case of the left-most column in
Architecture in which all Movable Units have MDC
In
The essential feature of
-
- State #1: IMD active, and next upstream unit active
[Conclusion: The IMD is not the upstream activity frontier, in which case communications are left unaltered, as per (4) and (5) among the General Principles above]; - State #2: IMD active, next upstream unit inactive
[Conclusion: The IMD is the upstream activity frontier, in which case downstream to upstream communication efforts from the IMD to the upstream repeater may be increased, as per (2) and (3) among the General Principles above]; - State #3: IMD inactive, next upstream unit active
[Conclusion: The upstream unit is the downstream activity frontier, in which case communications efforts from the IMD to the upstream repeater may be increased, as per (2) and (3) among the General Principles above]; - State #4: IMD inactive, next upstream unit inactive [Conclusion: Probable quiescent state, in which case communications efforts from the IMD to the upstream repeater may be decreased, as per (6) and (7) among the General Principles above];
- State #1: IMD active, and next upstream unit active
The activity state of the IMD is signaled upstream. Embodiments of the invention with a greater or lesser number of options for each contingency are possible.
In addition to the features which parallel those of
-
- If the unit activity status differs from each of its neighbors, then there is a possibility that the unit is lost or misplaced—as per (9) among the General Principles above—and four basic remedial actions are indicated in the figure;
- If the activity status of three consecutive units is negative—i.e. all three are not moving, then the level of certainty of a quiescent state [designated as “probable” ] is greater than the level of certainty if only two consecutive units are non-moving [in which case the designation is “possible” ]. The distinction between “possible” and “probable” may be used for decision making in terms of (i) whether to decrease the assiduousness of communication between the involved units, and (ii) if there is to be such a decrease, the extent of the decrease.
a) It shows the same four States and possible actions for communicating with its downstream neighbor;
b) It shows two states and possible actions for communicating with the SU (only two states [v.i.z. (i) final repeater moving, and (ii) final repeater not moving], since the SU by definition cannot be in motion); and
c) Since there is no opportunity to compare three consecutive moving units, the additional features of the general repeater [(i) lost/misplaced detection, and (ii) assessment of level of certainty of quiescent state] are not present.
In the case of a negative activity signal received from the downstream neighbor, a possibly quiescent state (of motion) exists, and the listed options R1-R10 address this circumstance. Options R1-R4 and R10 are the same as those shown in
One aspect of
Algorithms are possible which, in the event that the immediately downstream unit provides no activity signal, look further downstream for such a signal.
Referring to
-
- a) looking further upstream than the adjacent unit;
FIG. 24B shows an algorithm which looks at the two next upstream units (designated U+2 and U+3) beyond the unit which is adjacent to the IMD (designated U+1). If the information is obtained from U+2, then U+3 is not examined; If the information is not obtained from U+2, then U+3 is examined. Implicit in the algorithm is the concept that the motion state of unit U+1 is likely to be the same as that of U+2, and that the motion of U+2 is likely to be the same as that of U+3. Thus if the IMD is moving, and if the motion status of U+1 is unknown, but U+2 (or, if necessary, U+3) is known to be moving, then the conclusion is that the IMD is not likely to be the upstream activity frontier. On the other hand, if the IMD is moving, and if the motion status of U+1 is unknown, but U+2 (or, if necessary, U+3) is known not to be moving, then the conclusion is that the IMD may be the upstream activity frontier. In each case, conclusions based on U+2 are more reliable than those based on U+3. Clearly, it would be possible to allow the system to look even further upstream, i.e. at U+4, etc., which would be desirable, as shown inFIG. 24B , if neither of unit U+2 nor unit U+3 had MDC; - b) [again referring to
FIG. 24A ] looking at GPS or signal quality information to try to determine the motion status of the IMD with respect to unit U+1. Note thatFIG. 24B also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U+2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 24A ] simply making the assumption that the IMD is the upstream activity frontier (i.e. “err” on the side of more robust communications), and selecting one of the options led to from Circle N, which increase the assiduousness of upstream communications from the IMD; This approach is also indicated as an option inFIG. 24B , in the event that neither of U+2 nor U+3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further upstream than the adjacent unit;
The other difference between
Referring again to
-
- a) looking further upstream than the adjacent unit;
FIG. 24C shows an algorithm which looks at the two next upstream units (U+2 and U+3) beyond the unit which is adjacent to the IMD (U+1). If the information is obtained from U+2, then U+3 is not examined; If the information is not obtained from U+2, then U+3 is examined. As was the case withFIG. 24B , implicit in the algorithm is the concept that the motion state of unit U+1 is likely to be the same as that of U+2, and that the motion of U+2 is likely to be the same as that of U+3. Thus if the IMD is not moving, and if the motion status of U+1 is unknown, but U+2 (or, if necessary, U+3) is known to be moving, then the conclusion is that unit U+1 may be the downstream activity frontier, and options include efforts to increase the assiduousness of communications between U and U+1. On the other hand, if the IMD is not moving, and if the motion status of U+1 is unknown, but U+2 (or, if necessary, U+3) is known not to be moving, then the conclusion is that there may be an overall quiescent state, and options to decrease the assiduousness of communications between U and U+1 may be undertaken. As was the case withFIG. 24B , (i) in each case, conclusions based on U+2 are more reliable than those based on U+3; and (ii) clearly, it would be possible to allow the system to look even further upstream, i.e. at U+4, etc., which would be desirable, as shown inFIG. 24C , if neither of unit U+2 nor unit U+3 had MDC; - b) [again referring to
FIG. 24A ] looking at GPS or signal quality information to try to determine the motion status of the IMD with respect to unit U+1. Note thatFIG. 24C also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U+2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 24A ] simply making the assumption that the lack of IMD motion is part of an overall quiescent state, and therefore selecting one of the options led to from Circle Q, which decrease the assiduousness of upstream communications from the IMD; This approach is also indicated as an option inFIG. 24C , in the event that neither of U+2 nor U+3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further upstream than the adjacent unit;
Accordingly, four additional sets of options in
-
- Case 1: repeater unit in motion, no upstream activity signal from MD/A/P;
- Case 2: repeater unit in motion, no downstream activity signal from MD/A/P;
- Case 3: repeater unit in not in motion, no upstream activity signal from MD/A/P; and
- Case 4: repeater unit in not in motion, no downstream activity signal from MD/A/P.
- Case 1: repeater unit in motion, no upstream activity signal from MD/A/P;
Regarding Case 1 (immediately above): Referring to
-
- a) looking further upstream than the adjacent unit;
FIG. 25D shows an algorithm which looks at the two next upstream units (U+2 and U+3) beyond the unit which is next upstream from the repeater (U+1). The algorithm is conceptually identical to that shown inFIG. 24B : If the information is obtained from U+2, then U+3 is not examined; If the information is not obtained from U+2, then U+3 is examined; If the information is not obtained from either U+2 or U+3, looking further upstream is a possibility; - b) [again referring to
FIG. 25A ] looking at GPS or signal quality information to try to determine the motion status of the repeater unit with respect to unit U+1. Note thatFIG. 25D also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U+2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 25A ] simply making the assumption that the repeater unit is the upstream activity frontier, and selecting one of the options led to from Circle E, which increase the assiduousness of upstream communications from the repeater unit; This approach is also indicated as an option inFIG. 25D , in the event that neither of U+2 nor U+3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further upstream than the adjacent unit;
Regarding Case 2: Referring to
-
- a) looking further downstream than the adjacent unit;
FIG. 25C shows an algorithm which looks at the two next downstream units (designated U−2 and U−3) beyond the unit which is adjacent to the repeater unit (designated U−1). If the information is obtained from U−2, then U−3 is not examined; If the information is not obtained from U−2, then U−3 is examined. Implicit in the algorithm is the concept that the motion state of unit U−1 is likely to be the same as that of U−2, and that the motion of U−2 is likely to be the same as that of U−3. Thus if the repeater is moving, and if the motion status of U−1 is unknown, but U−2 (or, if necessary, U−3) is known to be moving, then the conclusion is that the repeater unit is not likely to be the downstream activity frontier. On the other hand, if the repeater unit is moving, and if the motion status of U−1 is unknown, but U−2 (or, if necessary, U−3) is known not to be moving, then the conclusion is that the repeater unit may be the downstream activity frontier. In each case, conclusions based on U−2 are more reliable than those based on U−3. Clearly, it would be possible to allow the system to look even further downstream, i.e. at U−4, etc., which would be desirable, as shown inFIG. 25C , if neither of unit U−2 nor unit U−3 had MDC; - b) [again referring to
FIG. 25A ] looking at GPS or signal quality information to try to determine the motion status of the repeater unit with respect to unit U−1. Note thatFIG. 25C also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U−2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 25A ] simply making the assumption that the repeater unit is the downstream activity frontier (i.e. “err” on the side of more robust communications), and selecting one of the options led to from Circle C, which increase the assiduousness of downstream communications from the repeater unit; This approach is also indicated as an option inFIG. 25C , in the event that neither of U−2 nor U−3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further downstream than the adjacent unit;
Regarding Case 3 (hereinabove): Referring to
-
- a) looking further upstream than the adjacent unit;
FIG. 25F shows an algorithm which looks at the two next upstream units (U+2 and U+3) beyond the unit which is next upstream from the repeater (U+1). The algorithm is conceptually identical to that shown inFIG. 24C : If the information is obtained from U+2, then U+3 is not examined; If the information is not obtained from U+2, then U+3 is examined; If the information is not obtained from either U+2 or U+3, then looking further upstream is a possible option; - b) [again referring to
FIG. 25B ] looking at (GPS or signal quality information to try to determine the motion status of the repeater unit with respect to unit U+1. Note that FIG. 25F also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U+2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 25B ] simply making the assumption that the repeater unit is part of a local quiescent state, and selecting one of the options led to from Circle L, which decrease the assiduousness of upstream communications from the repeater unit; This approach is also indicated as an option inFIG. 25F , in the event that neither of U+2 nor U+3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further upstream than the adjacent unit;
Regarding Case 4 (hereinabove): Referring to
-
- a) looking further downstream than the adjacent unit;
FIG. 25E shows an algorithm which looks at the two next downstream units (U−2 and U−3) beyond the unit which is next upstream from the repeater (U−1). If the information is obtained from U−2, then U−3 is not examined; If the information is not obtained from U−2, then U−3 is examined; If the information is not obtained from either U−2 or U−3, then looking further downstream is a possible option; - b) [again referring to
FIG. 25B ] looking at GPS or signal quality information to try to determine the motion status of the repeater unit with respect to unit U−1. Note thatFIG. 25E also calls for the possible consideration of GPS and/or signal quality information, if MD/A/P data from U−2 and beyond is insufficient for a decision; - c) [again referring to
FIG. 25B ] simply making the assumption that the repeater unit is part of a local quiescent state, and selecting one of the options led to from Circle H, which decrease the assiduousness of downstream communications from the repeater unit; This approach is also indicated as an option inFIG. 25E , in the event that neither of U−2 nor U−3 offers MD/A/P information; and/or - d) taking no action.
- a) looking further downstream than the adjacent unit;
As was the case with
-
- a) the detection of a lost or misplace unit; and
- b) an increased level of certain about a the existence of a quiescent state when three consecutive units are each in a non-motion state.
If the upstream unit shows activity, then the listed options N1-N7 include (i) an increase in the assiduousness of upstream communications, based on the assumption that one can't rule out the next upstream unit being the downstream activity frontier; (ii) further evaluation based on an examination of either GPS or signal quality data; or (iii) no change in communication management. No signal from upstream calls for no action. An algorithm which does not increase the assiduousness of upstream communication in the event of a positive activity signal from upstream is possible, since in that circumstance, the IMD could be moving with the upstream unit. Algorithms which look further upstream than the adjacent communications unit (no matter which signal is received from that adjacent unit) are possible.
Responses L1-L7 to positive activity signals from an upstream unit are the same as those for the IMD without MDC (N1-N7). In addition, in the case of the repeater herein, if a positive activity signal is received from downstream, then consideration is given to the possibility that the repeater herein could be in a positive activity state, implying the possibility that all three adjacent units are moving together; In such a circumstance, there would be no need to increase the assiduousness of upstream communications.
If there is no signal from the upstream communications unit, the algorithm calls for no communication modification at the repeater unit described herein.
The response of the repeater unit without MDC to downstream activity information is conceptually parallel to its response to upstream activity information. A negative downstream activity signal leads to options H1-H7, which parallel options K1-K7 (except that the repetition rate of S1s is the subject of H4, while the repetition rate of S2s is the subject of K4). In addition, in the case of the repeater herein, if a positive activity signal is received from upstream, then consideration is given to the possibility that the repeater herein could be in a positive activity state, making it the downstream activity frontier; In such a circumstance, options which increase the activity of downstream communications are desirable (J2-J5). A positive downstream activity signal leads to options J1-J7, which parallel options L1-L7 (except that the repetition rate of S1s is the subject of J4, while the repetition rate of S2s is the subject of L4). In addition, in the case of the repeater herein, if a positive activity signal is received from upstream, then consideration is given to the possibility that the repeater herein could be in a positive activity state, implying the possibility that all three adjacent units are moving together; In such a circumstance, there would be no need to increase the assiduousness of downstream communications. Finally, if there is no signal from the downstream communications unit, the algorithm calls for no communication modification at the repeater unit described herein.
-
- considering GPS as the primary data (e.g. in an algorithm similar to that shown in
FIGS. 20-27C , and in which, optionally, one or more of MD/A/P information and signal quality information are secondary considerations); - considering signal quality is used as the primary data, with one or more of MD/A/P and GPS as secondary information;
- consider a blend of any two modalities as the primary data (e.g. [i] define a positive motion state if either of GPS or MD/A/P indicates activity, or [ii] define a positive motion state if both GPS and MD/A/P indicate activity);
- consider a blend of all three as the primary data (e.g. [i] define a positive motion state if any of GPS or signal quality or MD/A/P indicates activity, or [ii] define a positive motion state if any two out of three of GPS, signal quality and IMD/A/P indicate activity, or [iii] define a positive motion state if all of GPS, signal quality and MD/AP indicate activity, or [iv] define a positive motion state if signal quality and either of GPS or MD/A/P indicate activity, etc.)
- considering GPS as the primary data (e.g. in an algorithm similar to that shown in
Still other ways of blending the information will be apparent to those skilled in the art.
Even more complex algorithms result from the consideration of General Principle 12 hereinabove, i.e. that activity may be considered in a more “fine grained” manner than simply all or none. For example, a five state format could include (i) negative, (ii) weakly positive, (iii) intermediate positive, (iv) strongly positive, and (v) unknown. A multistate format (involving the same, a lesser number or a greater number of states) could be used for one or more of MD/A/P, GPS and signal quality information in a blended format.
In these systems with augmented motion detection capabilities, the basic goals are the same as those defined hereinabove, i.e. the use of motion information to optimize signal quality and battery drainage, each in both real time, and proactively.
The approach hereinabove general concerns tandem communication units with a “series” structure, i.e. unit U sends IMD information to unit U+1, which relays the information to unit U+2, etc. However, parallel communication elements, as illustrated in
For example, if both of (i) the link between U and U+1A, and (ii) the link between U+1B and U+2 are non-functioning, then U can communicate with U+2 via the route
U←→U+1B←→U+1A←→U+2. U could either send information to both U+1A and U+1B, or, if U was provided with the information that the best route is
U←→U+1B←→U+1A←→U+2, then U could send information only to U+1B. All of the aforementioned potentially applies in the reverse direction—i.e. U+2 sending information to U, but it is not necessarily a given that the optimum U+2 to U route is simply the inverse of the U to U+2 route, because an upstream transmitter may have different power output than a downstream one, because receiver characteristics may differ, and because of different transmission channels.
An example of the communication elements which may form the network shown in
-
- Unit U=IMD
- Unit U+1A=WD
- Unit U+1B=CPD
- Unit U+2=SU
One feature which increases the number of possible system paths in
An example of the communication elements which may form the network shown in
-
- Unit U=IMD
- Unit U+1A=WD
- Unit U+1B=CPD
- Unit U+2A=SU #1
- Unit U+2B=SU #2
- Unit U+3=CS.
(In this case, it would be unlikely that one SU would send IMD information to the other or to a downstream location on the way to the CS.)
In another example, unit U is the IMD; while high capability RFIDs could constitute units U+1A and U+1B; unit U+2A could be a WD; unit U+2B could be a CPD; and unit U+3 a SU. In yet another example, the IMD is unit U; different types of WD (one on a wrist and one embedded in clothing) could constitute units U+1A and U+1B; units U+2A and U+2B could be two different CPDs; and unit U+3 a SU.
As indicated for the case of the configuration shown in
The CCSI can be stored in one of the communication units designated as the master unit; For example, each communication element could pass its information to the CS or the SU. Alternatively the information obtained at each unit could be passed along to its neighbors, so that it is ultimately disseminated over the entire network, resulting in each member of the network having access to the CCSI.
The number of columns in
In one embodiment of the invention, a communications unit which stores all system-wide or all local communication information could be endowed with heuristic software so that, over a period of time, it learns certain patterns of activity of the IMD-owner which impact communications, and makes adjustments accordingly. This could involve turning down handshaking and position-confirming efforts during the IMD owner's sleep period (which could be determined by motion detecting apparatus in the IMD or in any device worn by or implanted in the IMD owner). Another example: On a certain night each week, the IMD owner goes bowling in a basement level area, or attends meetings in a basement level conference room. Communication adjustments could then be made in advance. It might be possible, for example, to strategically place the CPD so that it can adequately perform a repeater function with the IMD owner at the basement level. Alternatively, it might call for the installation of an SU at that location (either temporarily or permanently), which could directly access both (i) a telephone network or the internet, and (ii) an IMD owner communication device such as a CPD or WD.
-
- a) a routine S1 handshake signal from an upstream communications unit;
- b) a signal indicating that the upstream communications unit is not receiving this unit's S2: “S2 not received” signal
- c) one or more types of signal requesting an increase in power output (coming from either an upstream or a downstream communications unit, because that respective unit is either not receiving an expected handshake signal or is receiving a suboptimal quality signal);
- d) one or more types of signal requesting an increase in sensitivity of this unit's receiving apparatus (coming from either an upstream or a downstream communications unit, because that respective unit is either not receiving an expected handshake signal or is receiving a signal from this unit indicating receipt of suboptimal quality signals at this unit, or indicating absent [but expected signals] at this unit);
- e) signals indicating that a high quality signal has been received at either the upstream or the downstream unit;
- f) signals requesting user notification (These would be for a device which has such capability, e.g. a suitably configured SU, CPD, or WD);
- g) signals carrying GPS information from either an upstream or a downstream unit;
- h) signals carrying motion information from either an upstream or a downstream unit;
- i) signals indicating decreased battery voltage in either an upstream or a downstream unit;
- j) a routine S2 handshake signal from a downstream communication unit;
- k) a signal indicating that the downstream communications unit is not receiving this unit's S1: “S1 not received” signal;
- l) a signal representing the CCSI described hereinabove; and
- m) a signal which causes a notification device to indicate to an IMD owner that his consent is requested for the acceptance/installation of an instruction/program for the IMD from the CS.
The crux of these figures is that a copy of the instruction received downstream is transmitted upstream back to the sending source for comparison with the initially sent instruction. If the returned copy is the same as the initially transmitted one, it can be assumed that the instruction arrived at the point from which return occurred in un-corrupted form.
As shown in
-
- A) transmitted all the way from the CS/MD [central station and or medical doctor {i.e. a physician who desires to provide an instruction}] to the IMD, stored in a buffer memory, and then returned to the CS/MD, or
- 1) If the comparison indicates and uncorrupted transmission, the transmission task is complete and the instruction may be installed, enacted, etc.
- 2) If the comparison indicates a corrupted transmission
- a) if one or more relay units were used in the transmission, request a return of one or more of those relay's memory, to attempt to determine the point of corruption; Once the point is identified, attempt to bypass that point in the transmission process;
- b) if no relays were used, retransmit using one or more relays; or
- B) transmitted only a portion of the route from CS/MD to the IMD, e.g. from the CS/MD to Relay Unit #1, and then returned to the CS/MD for comparison.
- 1) If the comparison indicates an un-corrupted transmission, options are
- a) transmit the instruction from the memory of relay unit #1 to the next downstream unit (in the case shown in the figure, Relay Unit #2), then retransmit from Relay #2 to Relay #1 to confirm faithful transmission; Continue stepwise transmissions until the instruction reaches the IMD in un-corrupted form; or
- b) transmit the instruction from the CS/MD to the next downstream unit (in the case shown in the figure, Relay Unit #2), then retransmit from Relay #2 to CS/MD to confirm faithful transmission; Continue stepwise transmissions until the instruction reaches the IMD in un-corrupted form;
- 2) If any comparison indicates a corrupted transmission, attempt to bypass the unit responsible involved in the corrupted step. For example, if the return transmission from Relay Unit #1, when assessed at the CS/MD, does not match the initial instruction, attempt to bypass the potentially problematic unit; In this exemplary case, that would involve an attempted transmission from CS/MD) to Relay Unit #2 directly (i.e. not via Relay Unit #1), or an attempted transmission from CS/MD to IMD.
- A) transmitted all the way from the CS/MD [central station and or medical doctor {i.e. a physician who desires to provide an instruction}] to the IMD, stored in a buffer memory, and then returned to the CS/MD, or
a) one in which the copy is automatically sent upstream, upon receipt of a new instruction, and
b) one in which the upstream reflected copy of the instruction is only sent if, after receiving a signal that the instruction was received downstream, the upstream unit requests the copy.
Options if the upstream unit determines that the copy that it has received is correct include:
-
- a) if it is confirmed that the proper instruction has arrived at the IMD, instructing the
- IMD to install/enact the instruction;
- b) commanding the downstream unit which has properly received the instruction to
- forward the instruction on to the next downstream unit; and
- c) sending an additional instruction.
- a) if it is confirmed that the proper instruction has arrived at the IMD, instructing the
Options if the upstream unit determines that the copy that it has received is not correct include:
-
- a) notifying the system administrator;
- b) command the downstream unit to delete the previous instruction from its memory, and then re-transmit the instruction; and
- c) command the downstream unit to delete the corrupted segment of the previous instruction from its memory, and then re-transmit that segment.
Although the aforementioned discussion pertains to the verification of instructions transmitted downstream, it could also be used to verify the proper transmission of information in the upstream direction. Such upstream information could include a) patient data, b) confirmations of executed commands, and c) device self monitoring data. In the case of data, for example, data could be 1) stored in the IMD, 2) transmitted from the IMD to the CS; 3) re-transmitted from the CS to the IMD; 4) at the IMD, the data that was re-transmitted from the CS would be compared with the data which was initially transmitted from the IMD.
Other methods and apparatus for confirmation of un-corrupted distant receipt of a signal set are known in the art.
An alternative way of determining if certain types of instruction were properly delivered from the CS to the IMD is a functional evaluation of the IMD post instruction delivery.
-
- 1) the temporary disconnection of the IMD processor input from the IMD sensors outputs, and the substitution of test signals as processor inputs; and
- 2) the temporary disconnection of the input to either the IMD actuator circuits or the disconnection of the input to a more proximal point in the actuation process (i.e. a point after a therapy decision is made but before it is executed).
If the IMD is an ICD, examples of actuator circuits are circuits which supply the energy for cardiac pacing and defibrillation; and examples of more proximal points in the actuation process are circuits which activate the aforesaid energy supply circuits.
The test signals would reflect various scenarios that would, following the installation/enactment of a new instruction, result in an IMD action which differs from the expected action prior to the installation/enactment of the new instruction. Among the instructions which could be functionally evaluated are a) reprogramming of already existing software; and b) new software with different operating characteristics than the previous software, c) an improved software version which does not contain an error which was present in a previous version, and d) a patch for an already installed software version which contained an error.
For example: If the IMD is an ICD, a simple example is reprogramming the rate cutoff for detection of VT. Consider an instruction which reprograms the VT rate cutoff from 190 beats per minute (“BPM”) to 200 BPM. The test procedure could involve:
-
- a) changing the output so that the response to a test signal is not delivered to the patient; In the case of the ICD, it would mean that either (i) once VT is detected, neither anti-tachycardia pacing (“ATP”) nor shock is triggered, or (ii) ATP or shock is delivered to a dummy load;
- b) changing the processor input source from the ventricular sensing lead to the source of electrogram test signals [which could be a) transmitted from the CS, or b) from an internal test generator within the ICD];
- c) supplying the electrogram test signals [e.g. (i) supplying electrograms which simulate a heart rate of 199 BPM, with non-detection of VT being the expected response; and (ii) supplying electrograms which simulate a heart rate of 201 BPM, with detection of VT being the expected response];
- d) observing the response to the test signals
- e) at the completion of the test, changing the processor input source back to the ventricular sensing lead and restoring output routing so that ATP or shock is delivered to the patient.
Another example: replacing the electrogram analysis software with a more robust analysis package. The package could be one which more accurately discriminates between ventricular tachycardia and supraventricular tachycardia. The test procedure could involve: involve:
-
- a) changing the output so that the response to a test signal is not delivered to the patient;
- b) changing the processor input source from the ventricular sensing lead to the source of electrogram test signals;
- c) supplying the electrogram test signals (e.g. test signals designed/selected to determine if the new software properly distinguishes between VT and SVT);
- d) observing the response to the test signals
- e) at the completion of the test, changing the processor input source back to the ventricular sensing lead and restoring output routing so that ATP or shock is delivered to the patient.
Observing the response to the test signals (and thus determining if the new instruction resulted in the desired IMD performance) may involve (a) transmitting a copy or a representation of the processor output, (b) transmitting a copy or representation of the input to an actuator circuit, as defined hereinabove; (c) interrogating the IMD following the test procedure; or (d) combinations of (a)-(c). By analysis of this copy or representation, a remote person may determine if the new instruction
-
- a) has been properly received by the IMD; and
- b) whether the new instruction allows the IMD to function in the intended manner; and
- c) whether the new instruction compromises the functioning of any other IMD tasks
- (Examples would be (i) new software improves the sensitivity of VT detection but decreases the specificity of VT detection in an ICD; and (ii) new software compromises the functioning of the IMD by impairing the operation of another IMD program or a segment of another IMD program.)
In a preferred embodiment of the invention, the IMD would be capable of responding to a situation requiring the need for immediate therapy, if such situation occurs during the test procedure. This feature may be accomplished, as is shown in
-
- a) itself directly activate the IMD actuator circuit; or
- b) restore the input of the IMD actuator circuit to the output of Processor #1. In this case, it may
- (i) also switch the input of Processor #1 back to the real time signals from the IMD lead/sensor, etc.;
- (ii) provide Processor #1 with a copy of the signal(s) which triggered the interruption of the test procedure, such signals having been stored in memory; or
- (iii) (iii) perform both (i) and (ii).
Following the completion of therapy for the event which required immediate attention, the test procedure is completed. Following the completion of the test procedure, if it indicates the updated version of Processor #1 is functioning in a desirable way, Processor #2 may be updated with the new instruction.
For example, if VT requiring therapy occurs during a test of new VT detection software for Processor #1, the VT is detected by Processor #2. Processor #2 may then itself directly activate the IMD actuator, or may cause Processor #1 to evaluate the VT, after which Processor #1 would determine the response to the VT.
The aforementioned IMD test apparatus and methods may also be used to evaluate IMD performance even if no new instruction was delivered. This may be done:
a) as part of periodic IMD maintenance by the IMD;
b) as part of periodic IMD maintenance by a remote source;
c) in the event that there is a question (on a non-periodic basis) about whether the IMD will perform properly, such question based on:
(i) a determination that the aging process [e.g. of the battery, the sensor(s), etc.] may negatively impact IMD performance;
(ii) the IMD manufacturer or other authority having become aware that certain clinical scenarios do not result in optimum IMD performance; and/or
(iii) other considerations.
Encryption/Decryption
In order to minimize the chance that an unauthorized person could gain access to a patient's IMD, the techniques illustrated in
The appropriate key is stored in the memory of the remote station and of the IMD. The memory may be a write once only type, or a re-writeable type. As used hereinabove and hereinbelow, the term “key” is intended to include systems and methods of encryption at the sending end of a communication link, and decryption at the receiving end, as well as methods of password protection.
The key may be generated at the time the device is manufactured. In a preferred embodiment of the invention, the key would be generated at the time that the device is implanted. Since the identity of either a controlling physician or central station might then be known, a single corresponding key could then be generated and stored in the appropriate remote station.
An example of such patient data would be a waveform in a patient electrogram, or intervals between patient heartbeats, determined by an ICD. In the figure, the key generator within the IMD updates both the IMD memory and the memory of the remote station with a new key, either at the end of each session, or during a session.
IMD Owner's Permission to Access IMD
During certain scenarios, it may be impractical or undesirable to require the IMD owner's permission. For example, if the IMD is an ICD which is repeatedly shocking the owner for atrial fibrillation, and the owner is physically incapable of granting permission, it would be desirable to reprogram or inhibit the device without permission.
If, on the other hand, an elective reprogramming of the IMD is desirable, or if the download of new software is desirable, the permission of the IMD may be sought. Requiring such permission makes it less likely that an unauthorized person could gain access to the IMD.
-
- In
FIG. 40 , both the instruction/program/command for the IMD and a patient permission request are sent to an external device such as the CPD or WD. The external device notifies the patient of a permission request. The notification may be a telephone message, a tone indicating that a message is to be retrieved, etc. The message may state a) the source, b) the content/purpose of the instruction/program/command, c) a contact person/phone number that the IMD owner may communicate with to receive additional information, the level of urgency of the requested download (e.g. low urgency for software update; high urgency for arrhythmia in progress). If the IMD owner grants permission (e.g. by pressing a key or sequence of keys on the CPD), the IMD instruction is downloaded from the CPD or WD to the IMD and is installed/enacted. Three options are listed in the figure in the event of either a) no response, or b) a negative response. - In the approach shown in
FIG. 41 : a) the instruction is sent to a buffer or labile memory of the IMD and b) permission to install/enact is sent to the IMD owner via the WD or CPD. If the owner grants permission, he so indicates via the WD or CPD, which signals the IMD to install/enact the instruction stored in its buffer/labile memory. If permission is not granted, three options are listed in the figure including the possibility of deleting the instruction from the buffer/labile memory. - In the approach shown in
FIG. 42 , the initial action by the person desiring to issue an IMD instruction is only to send a permission request to the IMD owner. If permission is granted, then the IMD instruction is sent to the IMD, and confirmation of installation or of enacting the instruction is sent back to the CS or MD who sent the instruction.
- In
Formats for outside access to an IMD in relationship to IMD owner permission include:
1) Under all circumstances, no outside access without IMD-owner permission;
2) IMD access without requesting permission in the event of an emergency, emergency defined in advance, and IMD owner, in advance, grants emergency access rights [to one or more individuals or centers or to all centers or individuals];
3) IMD access without requesting permission if
-
- (a) emergency in progress;
- (b) person obtaining access knows one or more passwords and/or one or more encryption keys; or
- (c) both (a) and (b)
4) IMD access under all circumstances, if in judgment of medical professional access is warranted.
A first locator unit 4300 contains transmitter 4302 which emits locator signals for detection by a receiver 4304 in the second locator unit 4306. The presence and quality of the signals from 4302 are evaluated by assessment device 4308, and the assessment may be shared with other units in the system. The information may be used for (a) modifying the path and entities which communicate, (b) modifying the communication parameters (e.g. power output, sensitivity, signal compression, transmission rate, etc) of one or more of the communicating units, (c) producing an alarm or other means of notifying either a patient, a user of the medical device, a person who can contact the patient or someone in proximity to the patient. The goal is to optimize communications between the medical device 4310 and the remote station 4312.
System architectures which use both signal strength and the detection of motion are possible, and various configurations will be determinable to those skilled in the art.
There has thus been shown and described novel apparatus and methodology for controlling an implantable medical device which fulfills all the objects and advantages sought therefor. Many changes, modifications, variations and other uses and applications of the subject invention will, however, become apparent to those skilled in the art after considering this specification and the accompanying drawings which disclose the preferred embodiments thereof. All such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention, which is to be limited only by the claims which follow.
Claims
1.-43. (canceled)
44. A medical treatment system having a medical device which allows a person using the device access to a medical expert that can communicate with the medical device from a remote site, said system comprising, in combination:
- (A) an electronic medical device (EMD) unit comprising, in combination: (1) a first wireless transmitting/receiving (T/R) device for transmitting information to, and for receiving at least one control signal from, a plurality of remote locations; (2) a medical treatment device, coupled to said first T/R device, for treating said person in response to control signals applied thereto;
- (B) a remote station (RS) unit at said remote location including: (1) a first input device, responsive to a medical expert, for producing at least one real time remote control signal for controlling said EMD; (2) a second transmitting/receiving (T/R) device, coupled to said input device, for electronic communication with the first T/R device of said remotely located EMD; and
- (C) at least one communication relay unit, x said communication relay unit(s) numbered from “1” to “x”, each yth communication relay unit including a (y+2)th communication relay transmitting/receiving (T/R) device for communicating with at least two of (i) the EMD, (ii) the RS, (iii) one of said communication relay units, and (iv) at least one other communication relay unit, wherein (1) x is an integer which is at least the integer 1 (2) y is an integer ranging from the integer 1 to the integer x; and
- wherein at least one of said units is a first unit further comprising: (a) a first global positioning system, for determining a location of said first unit; (b) a first communication quality assessment device, coupled to said first global positioning system, for assessing the expected quality of communication signals to be received by the T/R device associated with at least one of (i) said first unit and (ii) at least one other of said units, and for producing a first communication quality signal in dependence upon the respective expected quality of said communication signals; and (b) a first mode selection device coupled to said respective, associated T/R device and said first communication quality assessment device for selecting the mode of communication with at least one other one of said units, in response to receipt of said communication quality signal from said communication quality assessment device; thereby to select a mode of communication in dependence upon the current location of said unit and to improve the communication of said EMD unit and said RS unit;
45.-47. (canceled)
48. The medical treatment system defined in claim 44, wherein, upon the detection of a location, a respective mode selection device of said at least one first unit is operative to control at least one of:
- (i) the selection of at least one other unit with which said at least one first unit communicates;
- (ii) a power output for said T/R device of said first unit;
- (iii) a signal sensitivity for said T/R device of said first unit;
- (iv) at least one transmission frequency for said T/R device of said first unit;
- (v) an output signal modulation type for said T/R device of said first unit;
- (vi) a selection of at least one of a connection via (a) a radiofrequency link, (b) Internet, (c) a hard wire connection, for said T/R device of said first unit;
- (vii) a rate of information transfer;
- (viii) a method of signal encoding; and
- (ix) a message repetition frequency.
49. The medical treatment system defined in claim 44, wherein:
- (a) the respective communication quality assessment device includes a memory for storing a location of at least one stationary communication unit selected from the group consisting of (i) a stationary remote station, and (ii) at least one stationary communication relay unit; and
- (b) said global positioning system is operative to repeatedly determine the spatial relationship between said at least one first unit and at least one of (i) said stationary remote station and (ii) said at least one stationary communication relay unit.
50. The medical treatment system defined in claim 44, wherein:
- (1) the global positioning system of said at least one first unit is coupled to the respective T/R device of said at least one first unit, for transmission of respective labeled coordinate information including: (a) information which identifies said respective first unit; and (b) location information relating to said respective first unit;
- (2) an at least one other second unit includes:
- (a) a respective second communication quality assessment device, coupled to the respective T/R device of said second unit, for receipt of said labeled coordinate information from said at least one first unit, and for producing a respective second communication quality signal in dependence upon said labeled coordinate information; and
- (b) a second mode selection device coupled to said respective T/R device of said second unit and to said second communication quality assessment device, for selecting the mode of communication between at least one pair of units, each said pair comprising (i) said second unit and (ii) a first unit, in response to receipt of said respective second communication quality signal from said second communication quality assessment device;
- whereby said second communication quality assessment device is responsive to said location information from said at least one first unit, to determine if said at least one pair of units is in an acceptable location for communication.
51. The medical treatment system defined in claim 50, wherein
- (a) said at least one second unit further comprises a second global positioning system, coupled to said second communication quality assessment device, for determining a location of said second unit;
- (b) said at least one second communication assessment device is operative to utilize location information from each pair of units wherein one member of the pair is selected from said at least one first unit and the other member of the pair is selected from said at least one second unit, to determine at least one of: (i) a change in the position of each of the two members of each pair of two units; (ii) the presence of a motionless state of a pair, in which neither member of such pair of said units is moving, and (iii) the presence of a state in which at least one member of a pair of said units is moving.
52. The medical treatment system defined in claim 51, wherein
- (a) at least one of said second units is a local control unit;
- (b) at least two of said first units transmit respective labeled coordinate information to said at least one local control unit;
- (c) the communication quality assessment device of said local control unit is operative to analyze all received location information and to determine optimization information comprising at least one of (i) an optimal route for communications among said second unit and said at least two first units, and (ii) optimal communication parameters for said second unit and said at least two first units;
- (d) the communication quality assessment device of said local control unit is further coupled to the T/R device of said local control unit, to cause said T/R device to transmit said optimization information, for each first which transmitted said respective labeled coordinate information; and
- (e) the T/R device of each of said first units is coupled to the respective communication quality assessment device of said first units;
- wherein (i) each of said first units transmits respective labeled coordinate information to said local control unit; (ii) the communication quality assessment device of said local control unit determines respective optimization information for said first units; (iii) said optimization information is transmitted to said first units, and supplied to said respective mode selection device of said first units;
- thereby to improve communication among said local control unit and said at least two first units.
53. The medical treatment system defined in claim 51, comprising one second unit and a plurality of first units, wherein,
- (a) each of a plurality of first units transmits respective labeled coordinate information to said one second unit;
- (b) the communication quality assessment device of said second unit is operative to analyze all received location information and determine optimization information comprising at least one of (i) a route for improved communication among said second unit and said plurality of first units, and (ii) parameters for improved communication among said second unit and said plurality of first units;
- (c) the communication quality assessment device of said second unit is further coupled to the T/R device of said second unit, to cause said device to transmit said optimization information; and
- (d) the T/R device of each of said plurality of first units is coupled to the respective communication quality assessment device of each of said first unit;
- wherein (i) each of said plurality of first units transmits respective labeled coordinate information to said second unit; (ii) the communication quality assessment device of said second unit determines said optimization information for said second unit and said plurality of first units; (iii) said optimization information is transmitted to said first units, and passed to each said respective mode selection device;
- whereby said second unit is a master control unit;
- thereby to optimize communications between said EMD unit and said RS unit.
54. The medical treatment system defined in claim 53, wherein:
- (a) the communication quality assessment device of said master control unit includes a memory for storing a location of all stationary units; and
- (b) said communication quality assessment device of said master control unit is operative to determine the spatial relationship between each said stationary unit, and each other unit.
55. The medical treatment device system defined in claim 52, wherein said communication parameters include at least one of:
- (i) a choice of power output for at least one T/R device;
- (ii) a choice of signal sensitivity for at least one T/R unit;
- (iii) a choice of at transmission frequency for at least one T/P unit;
- (iv) a choice of output signal modulation type for at least one T/R unit;
- (v) a choice of the rate of information transfer;
- (vi) a choice of the method of signal encoding; and
- (vii) a choice of message repetition frequency.
56. The medical treatment device system defined in claim 53, wherein said communication parameters include at least one of:
- (i) a choice of power output for at least one T/R device;
- (ii) a choice of signal sensitivity for at least one T/R unit;
- (iii) a choice of at transmission frequency for at least one T/R unit;
- (iv) a choice of output signal modulation type for at least one T/R unit;
- (v) a choice of the rate of information transfer;
- (vi) a choice of the method of signal encoding; and
- (vii) a choice of message repetition frequency.
57. The medical treatment system defined in claim 51, wherein:
- (a) the T/R device of at least one additional unit is operative to (i) receive said labeled coordinate information from said at least one first unit, and (ii) re-transmit said information;
- (b) the T/R device of said at least one second unit is operative to receive said re-transmitted labeled coordinate information; and
- (c) the mode selection device of said at least one second unit is operative to select the mode of communication between: (1) said at least one second unit and (2) at least one of: (i) said at least one first unit, which initially transmitted said coordinate information, (ii) said at least one additional, which re-transmitted said coordinate information, and (iii) yet one other unit;
- thereby to allow position information of a unit to be propagated among the medical treatment system units, to optimize communications within the medical treatment system.
58. The medical treatment system defined in claim 52, wherein:
- (a) the T/R device of at least one more unit is operative to (i) receive said optimization information from said at least one second unit, and (ii) re-transmit said optimization information;
- (b) the T/R device of said at least one first unit is operative to receive said re-transmitted optimization information; and
- (c) the selection device of said at least one first unit is operative to select the mode of communication between (1) said at least one first unit and (2) at least one of: (i) said at least one second unit, which initially transmitted said optimization information, (ii) said at least one more unit, which re-transmitted said optimization information, and (iii) yet one other unit;
- thereby to allow communication optimization information to be propagated among the medical treatment system units, to optimize communications within the medical treatment system.
59.-63. (canceled)
64. A medical treatment system having a medical device which allows a person using the device access to a medical expert that can communicate with the medical device from a remote site, said system comprising, in combination:
- (1) an electronic medical device (EMD) unit comprising, in combination: (a) a first wireless transmitting/receiving (T/R) device for transmitting information to, and for receiving at least one control signal from, a plurality of remote locations; (b) a medical treatment device, coupled to said first T/R device, for treating said person in response to control signals applied thereto;
- (2) a remote station (RS) unit at said remote location including: (a) a first input device, responsive to a medical expert, for producing at least one real time remote control signal for controlling said EMD unit; (b) a second transmitting/receiving (T/R) device, coupled to said input device, for electronic communication with the first T/R device of said remotely located EMD unit; and
- (3) at least one communication relay unit, x said unit(s) numbered from “1” to “x”, each yth unit including: (a) a (y+2)th communication relay transmitting/receiving (T/R) device for communicating with at least two of (i) the EMD unit, (ii) the RS unit, (iii) one of said communication relay units, and (iv) at least one other communication relay unit; (b) a yth communication quality assessment device for assessing at least one of the expected and the actual quality of communications signals to be received by said (y+2)th communication relay T/R device from at least one of (i) said EMD unit, (ii) said RS unit, and (iii) said at least one other communication relay unit, and for producing a yth communication quality signal in dependence upon the respective assessed quality of the communication signals; and (c) a yth mode selection device coupled to each of said respective (y+2)th T/R device and said respective communication quality assessment device for selecting the mode of communication with at least one of (i) said EMD unit, (ii) said RS unit, and (iii) said at least one other communication relay unit, in response to receipt of said respective communications quality signal from said respective communication quality assessment device;
- wherein (1) x is an integer which is at least the integer 1, and (2) y is an integer ranging from the integer 1 to the integer x;
- whereby communication between said EMD and said RS may be improved.
65.-104. (canceled)
105. A medical treatment and testing apparatus, for medical treatment of a person, which allows a remote station to perform testing on the apparatus from a remote location, said apparatus comprising, in combination:
- (A) an electronic medical device comprising, in combination: (1) first transmitting and receiving device (T/R) device; for transmitting information to, and for receiving at least one control signal from and a remote station; (2) at least one sensor for producing a sensor signal representing a physiologic state of a person; (3) a first processor, having an input and an output, for receiving said sensor signals, for making a decision related to medical therapy for said person, responsive to said sensor signals, and for producing a first therapy signal output representing said decision; (4) a medical treatment device, for applying medical treatment to said person; (5) an input switching device, having: (a) a plurality of inputs, including: (i) one input coupled to said first T/R device, for receipt of test signals, and (ii) at least one other input coupled to said at least one sensor, for receipt of sensor signals; (b) an output, coupled to said first processor input;
- said input switching device being responsive to a first control signal received from said first T/R device for selecting the input to be outputted; (6) an output switching device, having: (a) an input, coupled to said first processor output for receipt of said first processor therapy signal; (b) a plurality of outputs, including: (i) one output coupled to said medical treatment device; and (ii) one output coupled to said first T/R device, for transmission of test results; and said output switching device being responsive to a second control signal received from said first T/R device for selecting the output of said output switching device;
- (B) a remote station unit at said remote location, including: (1) a first input device, responsive to a technical expert, for producing at least one remote control signal for controlling and testing said medical device; (2) a second transmitting/receiving (T/R) device, coupled to said input device, for electronic communication with the first T/R device of said remotely located EMD unit; and (3) a first output device, coupled to said second T/R device, for receipt of said first therapy signal;
- wherein
- (I) In a first operating state, said input switching device: couples said sensor signal to said first processor input, and uncouples said first T/R device from said first processor input; and said output switching device: couples said first processor output to said medical treatment device; and uncouples said first processor output from said first T/R device; and
- (II) In a second operating state, said input switching device: uncouples said sensor signal from said first processor input, and couples said first T/R device to said first processor input; and said output switching device: uncouples said first processor output from said medical treatment device; and couples said first processor output to said first T/R device; and
- (III) said technical expert determines the choice of operating state by inputting control signals to said second T/R device which are transmitted to said first T/R device, and then passed to the input of each of said input switching device and said output switching device, for respective control thereof;
- (IV) said technical expert (a) applies test signals to said first input device, which are passed sequentially by said second T/R, said first T/R and said input switching device to said first processor input; and (b) receives the first processor output, which is passed sequentially by said output switching device, said first T/R device, and said second T/R device, for evaluation; whereby, in said first operating state, said medical treatment device is operative to provide treatment based on said sensor signals; and in said second operating state, said technical expert evaluates the response of said first processor to a test signal, thereby to determine whether said first processor is functioning properly.
106.-123. (canceled)
124. A medical treatment system having an implantable medical device, which provides location information pertaining to a person in whom the device is implanted, to facilitate communication between the device and a remote location, said system comprising:
- (1) electronic medical apparatus adapted to be implanted in a human, a so-called implantable medical device (“IMD”) comprising, in combination: (a) an IMD communications device for at least one of (i) transmitting IMD information signals to, and (ii) receiving at least one IMD control signal from
- at least one remote location; and (b) a medical treatment device, coupled to said IMD communications device, for treating said patient;
- (2) a first locator device, adapted to be located in the close vicinity of said human in whom the IMD is implanted, comprising a wireless first locator transmitting device, operative to transmit first locator signals;
- (3) a plurality of second locator devices, each comprising: (a) a second locator receiving device, operative to receive (i) said first locator signals, and (ii) at least one IMD signal, selected from the group consisting of (A) an IMD information signal, and (B) an IMD control signal; (b) at least one microprocessor, coupled to said second locator receiving device, for assessing the quality of the received first locator signals and for producing a communication quality signal in dependence upon said assessed quality; and (c) a second locator transmitting device, coupled to said at least one microprocessor, for transmitting (i) said communication quality signal and (ii) said at least one IMD signal when received;
- (4) a communication management device, comprising: (a) a communications device, for (i) receiving said communication quality signals; and (ii) transmitting a communication optimization signal; and (b) a controlling device, coupled to said communications device, for (i) analyzing said received communication quality signals; and (ii) causing said communications device to transmit said communication optimization signal providing information for optimizing communications between said IMD and a selected one of said second locator devices, based on said received communication quality signals;
- whereby said first and second locator devices provide information about the location of said IMD without direct interaction with the IMD, thereby to improve communication with the IMD.
125. The medical treatment system defined in claim 124, wherein said communication optimization signal indicates a selection of one second locator device from among said plurality of second locator devices that provides a best communications quality with said IMD, thereby to indicate an optimum choice among said second locator devices for communication with said IMD.
126. The medical treatment system defined in claim 125, wherein said IMD communications device is further operative to receive said communication optimization signal and, based on the information contained therein, to optimize communications with at least one of said second locator devices.
127. The medical treatment system defined in claim 125, wherein at least one of said second locator devices is further operative to receive said communication optimization signal and, based on the information contained therein, to optimize communications with said IMD.
128. The medical treatment system defined in claim 124, wherein
- (i) said communication optimization signal is an alarm signal; and
- (ii) said alarm signal is produced by said communication management device if each of said received communication quality signal indicates a signal quality which is less than a given value, said given value reflecting inadequate signal quality for communication.
129. The medical treatment system defined in claim 125, further comprising a remote station (“RS”), comprising
- (a) a RS communications device for at least one of (i) receiving IMD information signals from at least one of said second locator devices, and (ii) transmitting at least one IMD control signal to at least one of said second locator devices; and
- (b) a RS controlling device, coupled to said RS communications device, for processing said IMD information;
- whereby said remote station is operative to provide supervisory services for the management of said IMD.
130. The medical treatment system defined in claim 129, wherein said RS communications device is further operative to receive said communication optimization signal and, based on the information contained therein, to optimize communications between said RS and at least one of said second locator devices.
131. A medical treatment system having an implantable medical device, which provides location information pertaining to a person in whom the device is implanted, to facilitate communication between the device and a remote location, said system comprising:
- (1) electronic medical apparatus adapted to be implanted in a human person, a so-called implantable medical device (“IMD”) comprising, in combination: (a) an IMD communications device for at least one of (i) transmitting IMD information signals to, and (ii) receiving at least one IMD control signal from
- at least one remote location; (b) a medical treatment device, for treating said person; and (c) a first processor, coupled to each of said IMD communications device and said medical treatment device, wherein said processor is operative to (i) control said medical treatment device, and (ii) process said IMD signals; and
- (2) a first locator device, adapted to be located in the close vicinity of said human in whom the IMD is implanted, comprising a wireless first locator transmitting device, operative to repeatedly transmit first locator signals;
- thereby to allow for tracking of the location of said IMD without utilizing an IMD energy source.
132. The system defined in claim 131, wherein said first locator device and said IMD are mechanically linked, such that both are adapted to be implanted in said human, in whom both said devices continue to be mechanically linked.
133. The system defined in claim 131, wherein said first locator device and said IMD are not mechanically linked.
134. The system defined in claim 131, further comprising a plurality of second locator devices, each comprising:
- (a) a second locator receiving device, operative to receive said first locator signals; and
- (b) a second processor, coupled to said second locator receiving device, for (i) assessing the quality of the received first locator signals, if any, and (ii) producing a communication quality signal in dependence upon said assessed quality; and
- (c) a second locator transmitting device, coupled to said second processor, for transmitting said communication quality signal
- wherein the communication quality signals produced by a particular second locator device represent a distance between said first locator device and the respective second locator device; and
- whereby each of said second locator devices provides an assessment of the proximity between said IMD and said second locator device.
135. The system defined in claim 134, wherein each second processor is operative to cause the respective second locator transmitting device to transmit a zero communication quality signal, in the absence of a received first locator signal.
136. The system defined in claim 134, wherein
- (1) at least one of said second locator receiving devices is further operative to receive said IMD signals, selected from the group consisting of (A) IMD information signals, and (B) IMD control signals;
- (2) the respective second locator transmitting device is further operative to transmit said received IMD signals;
- (3) the respective second processor is further operative to cause said respective second locator transmitting device to transmit said received IMD signals;
- whereby said at least one second locator devices is operative to relay received IMD signals.
137. The system defined in claim 134, further comprising a communication management device, comprising:
- (a) a communications device, operative to (i) receive said communication quality signals; (ii) transmit a communication optimization signal; and (iii) receive said IMD signals, selected from the group consisting of (A) IMD information signals, and (B) IMD control signals; and to transmit said received IMD signals;
- (b) a communications processor, coupled to said communications device, operative to (i) analyze said received communication quality signals; (ii) generate a communications optimization signal providing information for optimizing communications with said IMD, based on said received communication quality signals; (iii) cause said communications device to transmit said communication optimization signal; and (iv) cause said communications device to transmit said received IMD signals;
- whereby said first and second locator devices provide information about the location of said IMD without direct interaction with the IMD, and
- whereby said communications device is operative to relay received IMD signals.
138. The system defined in claim 137, wherein, upon generation of a communications optimization signal indicating a quality of communication less than a threshold value of quality, said communications device processor is operative to cause a remedial action selected from the group consisting of:
- (a) alteration of an operating characteristic of said communications management device;
- (b) pausing said communications device to transmit a signal which causes an alteration of an operating characteristic of at least one second locator device, wherein said second locator receiving device is further operative to receive said signal and said second processor is further operative to cause said alteration;
- (c) causing said communications device to transmit a signal which causes an alteration of an operating characteristic of said electronic medical apparatus, wherein said IMD communication device is further operative to receive said signal and said first processor is further operative to cause said alteration; and
- (d) production of an alarm signal.
139. The system defined in claim 138, wherein,
- (a) said communication management device operating characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said communications device; (ii) a signal sensitivity for said communications device; (iii) at least one transmission frequency for said communications device; (iv) an output signal modulation type for said communications device; (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said communications device; (vi) a rate of information transfer by said communications device; (vii) a method of signal encoding by said communications processor; (viii) a message repetition frequency, for said communications device; and (ix) a selection of the device with which said communications management device communicates
- (b) said second locator device operation characteristic alteration comprises a remedial action selected from the group consisting of an alteration of (i) a signal sensitivity of at least one of said second locator receiving device; (ii) a method of analysis of said received first locator signals by at least one second processor; and (iii) a selection of the device with which said second locator device communicates; and
- (c) said electronic medical apparatus operating characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said IMD communications device; (ii) a signal sensitivity for said IMD communications device; (iii) at least one transmission frequency for said IMD communications device; (iv) an output signal modulation type for said IMD communications device; (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said IMD communications device; (vi) a rate of information transfer by said IMD communications device; (vii) a method of signal encoding by said first processor; (viii) a message repetition frequency, for said IMD communications device; (ix) and a selection of the device with which said electronic medical apparatus communicates.
140. The system defined in claim 136, further comprising a communication management device, comprising:
- (a) a communications device, operative to (i) receive said communication quality signals; and (ii) transmit a communication optimization signal; and
- (b) a communications processor, coupled to said communications device, operative to (i) analyze said received communication quality signals; (ii) generate a communications optimization signal providing information for optimizing communications with said IMD, based on said received communication quality signals; and (iii) cause said communications device to transmit said communication optimization signal;
- whereby said first and second locator devices provide information about the location of said IMD without direct interaction with the IMD, thereby to improve communication with the IMD.
141. The system defined in claim 140, wherein, upon generation of a communications optimization signal indicating a quality of communication less than a threshold value of quality, said communications device processor is operative to cause a remedial action selected from the group consisting of:
- (a) causing said communications device to transmit a signal which causes an alteration of an operating characteristic of at least one second locator device, wherein said second locator receiving device is further operative to receive said signal and said second processor is further operative to cause said alteration;
- (b) causing said communications device to transmit a signal which causes an alteration of an operating characteristic of said electronic medical apparatus, wherein said IMD communication device is further operative to receive said signal and said first processor is further operative to cause said alteration; and
- (c) production of an alarm signal.
142. The system defined in claim 141, wherein,
- (a) said second locator device operation characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a signal sensitivity of at least one of said second locator receiving device; (ii) a method of analysis of said received first locator signals by at least one second processor; and (iii) a selection of the device with which said second locator device communicates; and
- (b) said electronic medical apparatus operating characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said IMD communications device; (ii) a signal sensitivity for said IMD communications device; (iii) at least one transmission frequency for said IMD communications device; (iv) an output signal modulation type for said IMD communications device; (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said IMD communications device; (vi) a rate of information transfer by said IMD communications device; (vii) a method of signal encoding by said first processor; (viii) a message repetition frequency, for said IMD communications device; and (ix) a selection of the device with which said electronic medical apparatus communicates.
143. The system defined in claim 140, wherein
- (1) said communications device is further operative to receive said IMD signals, selected from the group consisting of (A) IMD information signals, and (B) IMD control signals; and is further operative to transmit said received IMD signals;
- (2) said communications processor is further operative to cause said communications device to transmit said received IMD signals;
- whereby said communications device is operative to relay received IMD signals.
144. The system defined in claim 143, wherein, upon generation of a communications optimization signal indicating a quality of communication less than a threshold value of quality, said communications device processor is operative to cause a remedial action selected from the group consisting of:
- (a) alteration of an operating characteristic of said communications management device;
- (b) causing said communications device to transmit a signal which causes an alteration of an operating characteristic of at least one second locator device, wherein said second locator receiving device is further operative to receive said signal and said second processor is further operative to cause said alteration;
- (c) causing said communications device to transmit a signal which causes an alteration of an operating characteristic of said electronic medical apparatus, wherein said IMD communication device is further operative to receive said signal and said first processor is further operative to cause said alteration; and
- (d) production of an alarm signal.
145. The system defined in claim 144, wherein,
- (a) said communication management device operating characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said communications device; (ii) a signal sensitivity for said communications device; (iii) at least one transmission frequency for said communications device; (iv) an output signal modulation type for said communications device; (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said communications device; (vi) a rate of information transfer by said communications processor; (vii) a method of signal encoding by said communications device; (viii) a message repetition frequency, for said communications device; and (ix) a selection of the device with which said communications management device communicates
- (b) said second locator device operation characteristic alteration comprises a remedial action selected from the group consisting of an alteration of (i) a signal sensitivity of at least one of said second locator receiving device; (ii) a method of analysis of said received first locator signals by at least one second processor; and (iii) a selection of the device with which said second locator device communicates; and
- (c) said electronic medical apparatus operating characteristic alteration comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said IMD communications device; (ii) a signal sensitivity for said IMD communications device; (iii) at least one transmission frequency for said IMD communications device; (iv) an output signal modulation type for said IMD communications device; (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said IMD communications device; (vi) a rate of information transfer by said IMD communications device; (vii) a method of signal encoding by said first processor; (viii) a message repetition frequency, for said IMD communications device; and (ix) a selection of the device with which said electronic medical apparatus communicates.
146. The system defined in claim 131, further comprising a remote station (“RS”) at said remote location including:
- (a) a RS transmitting/receiving (“T/R”) device, operative to transmit said control signals and to receive said IMD information signals; and
- (b) a RS processor, coupled to said RS T/R device, operative to process each of said control signals and said information signals;
- wherein said RS processor is further operative to cause said RS T/R to transmit said control signals.
147. They system defined in claim 146, further comprising
- (c) an input device, coupled to said RS processor, responsive to a human medical expert, operative to produce at least one IMD control signal for controlling said IMD, and
- (d) a display device, coupled to said RS processor, operative to display a representation of said received IMD information signals;
- wherein said IMD communications device is operative to receive said IMD control signal, and said medical treatment device is responsive to said IMD control signal for applying a treatment represented by said signal;
- whereby said remote human medical expert provides remote control signals to said IMD
148. The system defined in claim 146, wherein said RS processor is further operative to analyze said received IMD information signals, and to select a therapy choice based on said analysis; and wherein said RS processor is further operative to cause said RS T/R to transmit a control signal representing said therapy choice;
- whereby said RS operates as a medical expert system for providing control signals to said IMD.
149. The system defined in claim 146, wherein said RS T/R device is operative to communicate with said IMD over a path selected from the group:
- (i) IMD directly to said RS;
- (ii) IMD to a second locator device, and thence to said RS;
- (iii) IMD to a communication management device, and thence to said RS;
- (iv) IMD to a second locator device, thence to a communication management device, and thence to said RS;
- (v) RS directly to said IMD;
- (vi) RS to a second locator device, and thence to said IMD;
- (vii) RS to a communication management device, and thence to said IMD; and
- (viii) RS to a communication management device, thence to a second locator device, and thence to said RS.
150. The system defined in claim 131, wherein the IMD further comprises at least one sensor, coupled to said first processor, operative to sense a physiological state of said person and to produce a sensor output signal representing said physiologic state, wherein the receipt of said sensor output signal causes said first processor to cause said IMD communications device to transmit said IMD information signal representing the physiologic state indicated by said sensor output signal.
151. The system defined in claim 134, wherein
- (a) said first locator device further comprises (i) a first locator receiving device, operative to receive signals from said second locator transmitting device; (ii) a first locator processor, coupled to each of said first locator receiving device and said first locator transmitting device;
- (b) said second locator transmitting device is further operative to transmit second locator signals to said first locator receiving device;
- (c) said first locator receiving device provides said second locator signals to said first locator processor;
- (d) said first locator processor is operative to analyze the quality of said received signals and to detect a second locator signal quality less than a second threshold value; and
- (e) upon detection of said less than threshold value signal, said first locator processor is operative to cause a remedial action selected from the group (i) modify the operation of said first locator transmitting device; (ii) modify the operation of said first locator receiving device; and (iii) cause send first locator transmitting device to transmit an alternate communications optimization signal.
152. The system defined in claim 151, wherein
- (a) said second locator receiving device is further operative to receive said alternate communications optimization signal, and in response thereto to
- (b) in response thereto, said second processor is operative to cause a remedial action selected from the group (i) modify the operation of said second locator transmitting device; (ii) modify the operation of said second locator receiving device; and (iii) cause send second locator transmitting device to transmit a second communications optimization signal.
153. The system defined in claim 151, wherein
- (a) said modification of said first locator transmitting device comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said device; (iii) at least one transmission frequency for said device; (iv) an output signal modulation type for said device; (v) a selection of a connection mode from the group consisting of (A) a radiofrequency link,
- (B) the Internet, (C) a hard wire connection, for said device; (vi) a rate of information transfer by said device; (vii) a method of signal encoding by said first locator processor; and (viii) a message repetition frequency, for said device;
- (b) said modification of said first locator receiving device comprises a remedial action selected from the group consisting of an alteration of: (i) a signal sensitivity for said device; (ii) a selection of a connection mode from the group consisting of (A) a radiofrequency link,
- (B) the Internet, (C) a hard wire connection, for said device; (iii) a rate of information transfer by said device;
154. The system defined in claim 152, wherein
- (a) said modification of said second locator transmitting device comprises a remedial action selected from the group consisting of an alteration of: (i) a power output for said device; (iii) at least one transmission frequency for said device; (iv) an output signal modulation type for said device; (v) a selection of a connection mode from the group consisting of (A) a radiofrequency link,
- (B) the Internet, (C) a hard wire connection, for said device; (vi) a rate of information transfer by said device; (vii) a method of signal encoding by said first locator processor; and (viii) a message repetition frequency, for said device;
- (b) said modification of said second locator receiving device comprises a remedial action selected from the group consisting of an alteration of: (i) a signal sensitivity for said device; (ii) a selection of a connection mode from the group consisting of (A) a radiofrequency link,
- (B) the Internet, (C) a hard wire connection, for said device; (iii) a rate of information transfer by said device;
155. The system defined in claim 152, wherein said electronic medical apparatus is further operative to receive said second communication optimization signal, and to cause a remedial action selected from the group consisting of an alteration of:
- (i) a power output for said IMD communications device;
- (ii) a signal sensitivity for said IMD communications device;
- (iii) at least one transmission frequency for said IMD communications device;
- (iv) an output signal modulation type for said IMD communications device;
- (v) a selection of a connection mode from the group consisting of (a) a radiofrequency link,
- (b) the Internet, (c) a hard wire connection, for said IMD communications device;
- (vi) a rate of information transfer by said IMD communications device;
- (vii) a method of signal encoding by said first processor;
- (viii) a message repetition frequency, for said IMD communications device; and
- (ix) a selection of the device with which said electronic medical apparatus communicates.
156. The system defined in claim 137, further comprising alarm apparatus, comprising:
- (a) a notification device for producing at least one output selected from the group consisting of a sound, a light and a vibration; and
- (b) a receiving device, coupled to said notification device, for receiving said communication optimization signal;
- wherein said receiving device causes said notification device to produce said at least one output upon receipt of a communication optimization signal indicating an unacceptable quality of communication between said first and said second locator devices;
- thereby to notify at least one person of a potential communication limitation involving said IMD.
157. The system defined in claim 140, further comprising alarm apparatus, comprising:
- (a) a notification device for producing at least one output selected from the group consisting of a sound, a light and a vibration; and
- (b) a receiving device, coupled to said notification device, for receiving said communication optimization signal;
- wherein said receiving device causes said notification device to produce said at least one output upon receipt of a communication optimization signal indicating an unacceptable quality of communication between said first and said second locator devices;
- thereby to notify at least one person of a potential communication limitation involving said IMD.
Type: Application
Filed: Jan 17, 2017
Publication Date: Jul 6, 2017
Patent Grant number: 10751540
Inventor: JEFFREY A. MATOS (New Rochelle, NY)
Application Number: 15/407,633
